Arthrex® AR-2600SBS-7Recalls & reported problems
Arthrex, Inc. · SPEEDBRG IMPL SYS W/ PEEK SWVLK SP · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867160231), received between Nov 20, 2023 and Nov 22, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Mar 24, 2017Terminated
Some eyelets broke from SwiveLock Anchor on insertion.
Z-2046-2017 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPEAR CAME LOOSE DURING A SPEED BRIDGE OPERATION WHEN IT WAS IMPACTED INTO THE BONE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE. UPDATE NROE 06-NOV-2023: FURTHER INFORMATION REVEALED THAT THE SPEAR LOOSENS FROM THE HANDLE DURING IMPACTION. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE SAME DEVICE WAS USED ANYWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18189966 ↗MalfunctionNov 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPEAR CAME LOOSE DURING A SPEED BRIDGE OPERATION WHEN IT WAS IMPACTED INTO THE BONE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE. ***UPDATE NROE 06-NOV-2023: FURTHER INFORMATION REVEALED THAT THE SPEAR LOOSENS FROM THE HANDLE DURING IMPACTION. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE SAME DEVICE WAS USED ANYWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18174370 ↗
Other Fastener, fixation, biodegradable, soft tissue devices
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- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 reports
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 · each recall links to the FDA recall notice
- 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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