Arthrex® AR-2324BCSPRecalls & reported problems
Arthrex, Inc. · SwiveLock, SP BC 4.75MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex SwiveLock SP biodegradable anchor is used to secure soft tissue, most often in rotator cuff repair surgery. The 33 reports mostly describe the anchor or its inserter tip breaking during placement into bone, sometimes leaving fragments that were retrieved, along with anchors loosening, cracking or detaching from the inserter. There are no deaths and no injuries. No recalls name this device, and reports in the last 12 months have dropped from 17 to 6.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00888867384514), received between Apr 21, 2023 and Sep 11, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Break” (27 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break27
- Crack3
- Detachment of Device or Device Component3
- Device Dislodged or Dislocated1
- Fitting Problem1
- Physical Resistance/Sticking1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information10
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Break
Patient problems: Insufficient Information
MAUDE report 50732551 ↗MalfunctionFeb 19, 2026Break
ON 02-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2324BCSP 4.75 MM BIOCOMPOSITE SWIVELOCK ANCHOR HAD THE TIP OF THE INSERTER BREAK DURING INSERTION INTO THE BONE. ALL BROKEN FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-2324BCSP 4.75 MM BIOCOMPOSITE SWIVELOCK ANCHOR. THERE WAS NO SIGNIFICANT DELAY, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED. THE ISSUE OCCURRED DURING A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 5-FEB-2026: IT WAS CONFIRMED THAT THE BROKEN PIECE WAS THE SELF-PUNCHING EYELET OF THE SWIVELOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387139 ↗MalfunctionFeb 12, 2026Device Dislodged or Dislocated
ON 26-JAN-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2324BCSP BIOCOMPOSITE SWIVELOCK SP EXHIBITED WEAK FIXATION STRENGTH AND BECAME UNUSABLE DURING USE. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-2324BCSP BIOCOMPOSITE SWIVELOCK SP. THERE WAS NO SIGNIFICANT DELAY; NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 29-JAN-2026: IT WAS REPORTED THAT THE FIXATION STRENGTH OF THE DEVICE APPEARED WEAK DURING USE. THE IMPLANT PULLED OUT IMMEDIATELY AFTER DEPLOYMENT, WHICH INDICATED THE REDUCED FIXATION STRENGTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24324587 ↗MalfunctionFeb 9, 2026Positioning Failure
ON 20-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2324BCSP 4.75 MM BIOCOMPOSITE SWIVELOCK ANCHOR ENCOUNTERED RESISTANCE DURING INSERTION AND WAS SUBSEQUENTLY REMOVED. A NEW ANCHOR WAS OPENED AS A RESULT. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 23-JAN-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24295022 ↗MalfunctionDec 23, 2025Break; Break
ON 12/01/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-2324BCSP SWIVELLOCK EYELET TIP BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. A NEW ANCHOR WAS USED, AND INSERTION WAS COMPLETED WITHOUT ISSUE. NO DELAY TO CASE, NO PHOTOS PROVIDED, AND NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879897 ↗MalfunctionDec 9, 2025Break; Break
ON NOVEMBER 21, 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT THE TIP OF AN AR-2324BCSP 4.75 MM BIOCOMPOSITE SWIVELOCK® ANCHOR BROKE DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE FAILURE OCCURRED WHILE IMPACTING THE ANCHOR, AND THE FRAGMENT WAS RETRIEVED. THE PATIENT HAD AVERAGE BONE QUALITY, AND THE SITE WAS NOT PREPPED USING AN INSTRUMENT PRIOR TO INSERTION. THE EVENT CAUSED AN APPROXIMATE TWO-MINUTE DELAY, REQUIRING ADDITIONAL ANESTHESIA. THE PROCEDURE WAS COMPLETED USING AN AR-2324BCC BIOCOMPOSITE SWIVELOCK® SUTURE ANCHOR. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759185 ↗MalfunctionDec 1, 2025Break; Break
ON 11/11/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT THE DISTAL EYELET OF AN AR-2324BCSP 4.75 MM BIOCOMPOSITE SWIVELOCK ANCHOR BROKE DURING INSERTION INTO THE BONE HOLE. THE CASE WAS COMPLETED USING A REPLACEMENT AR-2324BCSP 4.75 MM BIOCOMPOSITE SWIVELOCK ANCHOR. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. NO SPECIFIC DETAILS WERE PROVIDED REGARDING THE TYPE OF SURGERY, BONE PREPARATION, OR BONE QUALITY. THERE WAS NO SIGNIFICANT DELAY, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE NOTED. NO PHOTOGRAPHS WERE TAKEN TO DOCUMENT THE EVENT. THE ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23682358 ↗MalfunctionSep 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 08/27/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO AR-2324BCFP SWIVELLOCK ANCHORS FELL OFF THE INSERTER WHILE INSERTING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO FRAGMENTS CREATED. NO DELAY TO THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23061648 ↗MalfunctionSep 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 08/27/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO AR-2324BCFP SWIVELLOCK ANCHORS FELL OFF THE INSERTER WHILE INSERTING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO FRAGMENTS CREATED. NO DELAY TO THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23061632 ↗MalfunctionSep 12, 2025Break; Crack; Break; Crack
ON 08/22/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS EXPERIENCED CRACKING WHEN ATTEMPTING TO ADVANCE THE SCREW. AS A RESULT, THEY OPENED THREE MORE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS FROM LOT 15419013 AND GOT SIMILAR RESULTS. THE CASE WAS COMPLETED WITHOUT COMPLICATIONS USING AN ALTERNATIVE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHOR FROM A DIFFERENT LOT. THIS ISSUE WAS IDENTIFIED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/27/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042900 ↗MalfunctionSep 12, 2025Break; Crack; Break; Crack
ON 08/22/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS EXPERIENCED CRACKING WHEN ATTEMPTING TO ADVANCE THE SCREW. AS A RESULT, THEY OPENED THREE MORE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS FROM LOT 15419013 AND GOT SIMILAR RESULTS. THE CASE WAS COMPLETED WITHOUT COMPLICATIONS USING AN ALTERNATIVE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHOR FROM A DIFFERENT LOT. THIS ISSUE WAS IDENTIFIED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/27/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042311 ↗MalfunctionSep 12, 2025Break; Crack; Break; Crack
ON 08/22/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS EXPERIENCED CRACKING WHEN ATTEMPTING TO ADVANCE THE SCREW. AS A RESULT, THEY OPENED THREE MORE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS FROM LOT 15419013 AND GOT SIMILAR RESULTS. THE CASE WAS COMPLETED WITHOUT COMPLICATIONS USING AN ALTERNATIVE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHOR FROM A DIFFERENT LOT. THIS ISSUE WAS IDENTIFIED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/27/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23041826 ↗MalfunctionSep 12, 2025Break; Break
ON 08/22/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS EXPERIENCED CRACKING WHEN ATTEMPTING TO ADVANCE THE SCREW. AS A RESULT, THEY OPENED THREE MORE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS FROM LOT 15419013 AND GOT SIMILAR RESULTS. THE CASE WAS COMPLETED WITHOUT COMPLICATIONS USING AN ALTERNATIVE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHOR FROM A DIFFERENT LOT. THIS ISSUE WAS IDENTIFIED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/27/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23041329 ↗MalfunctionSep 12, 2025Break; Break
ON 08/22/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS EXPERIENCED CRACKING WHEN ATTEMPTING TO ADVANCE THE SCREW. AS A RESULT, THEY OPENED THREE MORE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS FROM LOT 15419013 AND GOT SIMILAR RESULTS. THE CASE WAS COMPLETED WITHOUT COMPLICATIONS USING AN ALTERNATIVE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHOR FROM A DIFFERENT LOT. THIS ISSUE WAS IDENTIFIED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/27/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23039321 ↗MalfunctionSep 12, 2025Break; Break
ON 08/22/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS EXPERIENCED CRACKING WHEN ATTEMPTING TO ADVANCE THE SCREW. AS A RESULT, THEY OPENED THREE MORE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHORS FROM LOT 15419013 AND GOT SIMILAR RESULTS. THE CASE WAS COMPLETED WITHOUT COMPLICATIONS USING AN ALTERNATIVE AR-2324BCSP BIOCOMPOSITE SWIVELOCK ANCHOR FROM A DIFFERENT LOT. THIS ISSUE WAS IDENTIFIED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/27/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23039119 ↗MalfunctionAug 13, 2025Break; Break
ON 07/29/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2324BCSP 4.75 MM BIOCOMPOSITE SWIVELOCK® ANCHOR TIP DISLODGED. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025 THE IMPLANT WAS INSERTED, IMPACTED AND THE TIP DISLODGED. IT CAN NOT BE CONFIRMED THAT THE FRAGMENT WAS RETRIEVED HOWEVER IT DID NOT APPEAR TO BE IN THE PATIENT. THE PATIENT HAD HARD BONE. THERE WAS NO DELAY IN THE CASE. ANOTHER AR-2324BCSP 4.75 MM BIOCOMPOSITE SWIVELOCK® ANCHOR WAS USED TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795075 ↗MalfunctionMay 19, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-2324BCSP 4.75 MM BIOCOMPOSITE SWIVELOCK® ANCHORS PEEK EYELETS BROKE. THIS OCCURRED DURING A SUPRASPINATUS REPAIR ON (B)(6) 2025, WHERE THE PROPER TECHNIQUE GUIDE WAS FOLLOWED. THE FRAGMENTS WERE RETRIEVED, AND THE CASE CONTINUED USING AN AR-2324BCC, AND THE BONE WAS PREPPED USING A PUNCH. THERE WAS A SLIGHT DELAY OF ABOUT 5 MINUTES WITH NO ADDITIONAL ANESTHESIA REQUIRED.
Patient problems: Insufficient Information
MAUDE report 22045619 ↗MalfunctionMay 19, 2025Break; Break
ON 04/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-2324BCSP 4.75 MM BIOCOMPOSITE SWIVELOCK® ANCHORS PEEK EYELETS BROKE. THIS OCCURRED DURING A SUPRASPINATUS REPAIR ON (B)(6)2025, WHERE THE PROPER TECHNIQUE GUIDE WAS FOLLOWED. THE FRAGMENTS WERE RETRIEVED, AND THE CASE CONTINUED USING AN AR-2324BCC, AND THE BONE WAS PREPPED USING A PUNCH. THERE WAS A SLIGHT DELAY OF ABOUT 5 MINUTES WITH NO ADDITIONAL ANESTHESIA REQUIRED.
Patient problems: Insufficient Information
MAUDE report 22045005 ↗MalfunctionJan 10, 2025Break; Break
ON 12/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2324BCSP SWIVELOCK EYELETS BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/19/2024: THE PROCEDURE TOOK PLACE ON (B)(6) 2024. BOTH ANCHORS AND ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING A NEW AR-2324BCSP SWIVELOCK. THE CASE WAS SLIGHTLY DELAYED, ONLY BY A FEW MINUTES WITHOUT ADDITIONAL ANESTHESIA.
Patient problems: Insufficient Information
MAUDE report 21124891 ↗MalfunctionJan 10, 2025Break; Break
ON 12/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2324BCSP SWIVELOCK EYELETS BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/19/2024: THE PROCEDURE TOOK PLACE ON (B)(6) 2024. BOTH ANCHORS AND ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING A NEW AR-2324BCSP SWIVELOCK. THE CASE WAS SLIGHTLY DELAYED, ONLY BY A FEW MINUTES WITHOUT ADDITIONAL ANESTHESIA.
Patient problems: Insufficient Information
MAUDE report 21124646 ↗MalfunctionJan 3, 2025Fitting Problem; Fitting Problem
ON12/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCSP SWIVELOCK WOULD NOT STAY UP AND KEPT SLIDING DOWN. THIS WAS DISCOVERED DURING AN ACL REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING A NEW ONE. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068085 ↗MalfunctionDec 31, 2024Break; Break
ON 12/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCSP SWIVELOCK ANCHOR TIP BROKE DURING INSERTION. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING ANOTHER SWIVELOCK. ADDITIONAL INFORMATION RECEIVED ON 12/16/2024: THIS ISSUE OCCURRED IN THE CANNULA. THE CASE WAS COMPLETED USING ANOTHER AR-2324BCSP SWIVELOCK. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT ADMINISTERED.
Patient problems: Insufficient Information
MAUDE report 21047195 ↗MalfunctionDec 6, 2024Break; Break
ON 11/11/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (2) AR-2324BCSP SWIVELOCKS PEEK TIPS OF THE SWIVELOCK BROKE IN TWO PIECES. THIS OCCURRED DURING A ROTATOR CUFF ON (B)(6) 2024 WHILE TRYING TO COMPLETE THE SPEED BRIDGE TECHNIQUE, THE SURGEON USED A SELFPUNCHING SWIVELOCK AND THE PEEK TIPS OF THE SWIVELOCK BROKE IN TWO PIECES. 2 OF THEM BROKE WHILE TRYING TO IMPACT THE ANCHOR IN THE BONE. THE ANGLE OF IMPACTION WAS PERFECT EVERY TIME HE USED THE ANCHOR. THE PATIENT HAD A HARD BONE, BUT THAT SHOULD NOT BE A REASON FOR IT. THE FRAGMENT WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20866650 ↗MalfunctionDec 6, 2024Break; Break
ON 11/11/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (2) AR-2324BCSP SWIVELOCKS PEEK TIPS OF THE SWIVELOCK BROKE IN TWO PIECES. THIS OCCURRED DURING A ROTATOR CUFF ON (B)(6) 2024 WHILE TRYING TO COMPLETE THE SPEED BRIDGE TECHNIQUE, THE SURGEON USED A SELFPUNCHING SWIVELOCK AND THE PEEK TIPS OF THE SWIVELOCK BROKE IN TWO PIECES. 2 OF THEM BROKE WHILE TRYING TO IMPACT THE ANCHOR IN THE BONE. THE ANGLE OF IMPACTION WAS PERFECT EVERY TIME HE USED THE ANCHOR. THE PATIENT HAD A HARD BONE, BUT THAT SHOULD NOT BE A REASON FOR IT. THE FRAGMENT WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20866327 ↗MalfunctionJun 11, 2024Break; Break
ON 5/3/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324BCSP SWIVELOCK EYELET STARTED TO BEND DURING INSERTION AND, WHEN IT WAS MALLETED IN, SNAPPED OFF THE INSERTER. THE SURGEON ATTEMPTED TO RETENTION THE SUTURES IN ORDER TO SECURE THE EYELET BACK TO THE END OF THE INSERTER, BUT THE SAME THING OCCURRED, IT BENT AND SNAPPED OFF THE INSERTER. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 5/4/2023: THE EYELET SNAPPED OFF BUT WAS SECURED WITH THE SUTURE AND NEVER BECAME LOOSE INSIDE THE PATIENT, THIS MADE IT EASY TO REMOVE IT. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC RCR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER ANCHOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19512584 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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