Arthrex® AR-5100-08Recalls & reported problems
Arthrex, Inc. · GRAFTBOLT, TIBIAL 8MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00888867035751), received between Dec 2, 2016 and Mar 30, 2026 — classified as 1 injury, 19 malfunctions.
The most frequently reported specific device problem is “Break” (20 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break20
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Break
ON 10TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-5100-08. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715691 ↗MalfunctionMar 30, 2026Break
ON 10TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-5100-08. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714376 ↗MalfunctionJun 26, 2025Break; Break
ON 5TH JUNE 2025, IT WAS REPORTED BY ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-5100-08. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22337494 ↗MalfunctionJun 26, 2025Break; Break
ON 5TH JUNE 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-5100-08. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22337106 ↗MalfunctionJun 26, 2025Break; Break
ON 5TH JUNE 202, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-5100-08. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22337071 ↗MalfunctionJan 14, 2025Break; Break
ON 24TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2024. AR-5108 WAS USED TO PREPARE THE BONE SOCKET. THE ANCHOR BROKE DURING INSERTION AND NO FRAGMENTS WERE LEFT IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED BY USING ANOTHER NEW AR-5100-08.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21149698 ↗MalfunctionJan 14, 2025Break; Break
ON 24TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT SURGERY ON (B)(6) 2024. AR-5108 WAS USED TO PREPARE THE BONE SOCKET. THE ANCHOR BROKE DURING INSERTION AND NO FRAGMENTS WERE LEFT IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED BY USING ANOTHER NEW AR-5100-08.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21149662 ↗MalfunctionJan 14, 2025Break; Break
ON 24TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A RECONSTRUCTION OF POSTERIOR FORK LIGAMENT SURGERY ON (B)(6) 2024. AR-5108 WAS USED TO PREPARE THE BONE SOCKET. THE ANCHOR BROKE DURING INSERTION AND NO FRAGMENTS WERE LEFT IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED BY USING ANOTHER NEW AR-5100-08.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21149179 ↗MalfunctionJan 14, 2025Break; Break
ON 24TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT SURGERY ON (B)(6) 2024. AR-5108 WAS USED TO PREPARE THE BONE SOCKET. THE ANCHOR BROKE DURING INSERTION AND NO FRAGMENTS WERE LEFT IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED BY USING ANOTHER NEW AR-5100-08.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21149081 ↗MalfunctionDec 30, 2024Break; Break
ON 4TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A RIGHT KNEE JOINT ENDOSCOPIC CLEARANCE AND POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION AND MENISCUS FORMATION SURGERY ON 31ST OCTOBER 2024. AR-5108 WAS USED TO PREPARE THE BONE SOCKET. THE ANCHOR BROKE DURING INSERTION AND ALL FRAGMENTS WERE RETRIEVED FROM PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED BY USING ANOTHER NEW AR-5100-08.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036439 ↗MalfunctionSep 18, 2024Break; Break
ON 4TH SEPTEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, THE SHEATH BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2024. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER NEW AR-5100-08 GRAFTBOLT. ALL FRAGMENTS WERE RETRIEVED FROM PATIENT. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED. AR-5108 WAS USED TO PREPARE THE BONE SOCKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20244680 ↗MalfunctionSep 17, 2024Break; Break
ON 4TH SEPTEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN AN ACL RECONSTRUCTION SURGERY ON (B)(6) 2024. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER NEW AR-5100-08 GRAFTBOLT. ALL FRAGMENTS WERE RETRIEVED FROM PATIENT. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED. AR-5108 WAS USED TO PREPARE THE BONE SOCKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238486 ↗MalfunctionSep 17, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, THE SHEATH BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2024. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER NEW AR-5100-08 GRAFTBOLT. ALL FRAGMENTS WERE RETRIEVED FROM PATIENT. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED. AR-5108 WAS USED TO PREPARE THE BONE SOCKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238358 ↗MalfunctionSep 17, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-5100-08, GRAFTBOLT®, TIBIAL, 8 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN AN ANTERIOR FORK LIGAMENT RECONSTRUCTION REPAIR PROCEDURE ON(B)(6) 2024. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER NEW AR-5100-08 GRAFTBOLT. ALL FRAGMENTS WERE RETRIEVED FROM PATIENT. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20236394 ↗MalfunctionJan 22, 2024Break; Break
ON 1/2/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1588RT ACL TIGHTROPE RT AND AN AR-5100-08 GRAFTBOLT BROKE AS THE SURGEON WAS PULLING ON THE TIGHTROPE. THE CASE WAS COMPLETED USING ANOTHER AR-1588RT ACL TIGHTROPE RT AND AN AR-5100-08 GRAFTBOLT. ALL THE BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 18553250 ↗MalfunctionDec 28, 2023Break; Break
ON 2/20/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-5100-08 GRAFTBOLT SHEATH BROKE UPON IMPACT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 2/23/2023: THIS WAS DISCOVERED DURING AN ACL PROCEDURE AND COMPLETED USING ANOTHER AR-5100-08 GRAFTBOLT SCREW. THE SHEATH CRACKED ON IMPACT BUT DID NOT BREAK INTO PIECES.
Patient problems: Insufficient Information
MAUDE report 18413369 ↗MalfunctionDec 15, 2023Break; Break
ON 11/20/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-5100-08 GRAFTBOLT ANCHOR BROKE DURING INSERTION. ALL THE FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING ANOTHER R-5100-08 GRAFTBOLT. THIS WAS DISCOVERED DURING A RECONSTRUCTION OF ANTERIOR AND POSTERIOR FORK LIGAMENT PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 11/24/2023: THE CASE WAS DELAYED TWENTY MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18340753 ↗MalfunctionDec 27, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-5100-08 GRAFTBOLT SHEATH BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A RECONSTRUCTION OF THE POSTERIOR CRUCIATE LIGAMENT. CASE WAS COMPLETED USING ANOTHER AR-5100-08 GRAFTBOLT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 16050985 ↗MalfunctionOct 31, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY SALES REPRESENTATIVE VIA PHONE THAT AN AR-5100-08 GRAFTBOLT SHEATH BROKEN DURING INSERTION. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2022. ALL BROKEN FRAGMENTS WERE REMOVED, AND CASE WAS COMPLETED WITH ANOTHER AR-5100-08 GRAFTBOLT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15698292 ↗InjuryDec 2, 2016Break; Difficult to Remove
IT WAS REPORTED THAT WHILE PERFORMING AN ACL RECONSTRUCTION PROCEDURE, THE SURGEON WAS ATTEMPTING TO USE THE 8MM TIBIAL GRAFTBOLT. WHILE TRYING TO INSERT THE GRAFT BOLT SHEATH, THE TIP OF THE IMPLANT BROKE APART. MOST OF THE BROKEN IMPLANT WAS RETRIEVED, HOWEVER THE SURGEON WAS UNABLE TO REMOVE A SMALL PIECE OF THE IMPLANT. HE SECURED THE REMAINING PIECE BY PLACING AN INTERFERENCE SCREW NEXT TO THE IMPLANT AND FINISHED THE PROCEDURE. PATIENT IS AN (B)(6) MALE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6140671 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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