Arthrex® AR-1680BCRecalls & reported problems
Arthrex, Inc. · TENO SCRW BIO-COMP · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867020924), received between Aug 6, 2025 and Aug 6, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON 07/16/2025, A FACILITY REPRESENTATIVE REPORTED VIA EMAIL THAT ONE OF THEIR PATIENTS DEVELOPED A POST-OPERATIVE INFECTION IN THE LEFT SHOULDER FOLLOWING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2025. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE CASE: (QTY. 2) AR-2324BCCT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 3) AR-2323BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 1) AR-2324BCCTT BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR. (QTY. 1) AR-1680BC BIOCOMPOSITE-TENODESIS SCREW 8 X 12 MM. ABS-3101 BONESYNC FAST-SETTING DRILLABLE CALCIUM PHOSPHATE CEMENT (INJECTION) THE INFECTION WAS IDENTIFIED POST-OPERATIVELY, AND NO ADDITIONAL CLINICAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2025: THE PATIENT INITIALLY UNDERWENT ROTATOR CUFF REPAIR, BICEPS TENODESIS, AND DISTAL CLAVICLE EXCISION ON (B)(6) 2025. APPROXIMATELY TWO WEEKS AFTER SURGERY, SIGNS OF INFECTION EMERGED, INCLUDING PAIN, TENDERNESS, AND PURULENT DRAINAGE. CLINICAL EVALUATION CONFIRMED A LOCALIZED PURULENT SUBCUTANEOUS ABSCESS, WITH NO EVIDENCE OF INTRA-ARTICULAR INVOLVEMENT AND THE ROTATOR CUFF REMAINING INTACT. A CULTURE COLLECTED DURING ASSESSMENT REVEALED A SCANT AMOUNT OF CUTIBACTERIUM
Patient problems: Unspecified Infection
MAUDE report 22725956 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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