Arthrex® AR-9928BC-CPRecalls & reported problems
Arthrex, Inc. · BC ACHILLES SPDBRG W/ FT CC, 3.9 MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867389496), received between Jan 17, 2024 and Jan 25, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Physical Resistance/Sticking1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 1/5/20224, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO SWIVELOCK EYELETS FROM AN AR-9928BC-CP ACHILLES SPEEDBRIDGE KIT WOULD NOT DISENGAGE FROM THE INSERTER SHAFT. THE SHAFT WOULD BE PULLED ON TO BE REMOVED, BUT THE EYELET WOULD NOT STAY IMPLANTED. THE CASE WAS COMPLETED USING AN AR-8928BCJ-CP BIOCOMPOSITE ACHILLES SPEEDBRIDGE WITH JUMPSTART IMPLANT SYSTEM. THIS WAS DISCOVERED DURING AN ACHILLES REPAIR PROCEDURE ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 18579959 ↗MalfunctionJan 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 12/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9928BC-CP SPEEDBRIDGE KIT NEEDLE POPPED OFF OF THE SUTURE APPLICATION BEFORE PASSING. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT. DELAY LESS THAN 15 MINUTES. CASE COMPLETED USING FREE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531994 ↗
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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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