Arthrex® AR-1322-752SF-1Recalls & reported problems
Arthrex, Inc. · SUTR ANCH,FASTAK,SM BONE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867285002), received between Sep 17, 2020 and Dec 27, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
- Difficult to Remove1
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
MalfunctionDec 27, 2021Break
IT WAS REPORTED THAT DURING A SURGERY THE DEVICE WAS SCREWED INTO THE BONE TO THE PREDEFINED MARK. THE DEVICE THEN COULD NOT BE BROKEN OFF, AFTER SEVERAL ATTEMPTS THE WHOLE DEVICE BROKE OUT OF THE BONE. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. A SECOND DEVICE WAS USED TO FINISH THE SURGERY SUCCESSFULLY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 08-DEC-2021: IT WAS CONFIRMED THAT A NEW ANCHOR IS NOT NECESSARY AND THE SURGEON ONLY RINSED THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13087594 ↗InjurySep 17, 2020Break; Difficult to Remove
IT WAS REPORTED THAT WHEN THE ANCHOR WAS IMPLANTED, THE DRIVER BROKE LEAVING A "METALLIC SHINE", IN ADDITION TO THE ANCHOR ITSELF, IN THE PATIENT'S WRIST. DUE TO THIS EVENT, THE SURGERY TIME WAS EXTENDED. CURRENTLY, NO REVISION SURGERY IS SCHEDULED. SHOULD THE FRAGMENT DISTURB THE PATIENT, A REVISION SURGERY WILL BE SCHEDULED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. UPDATE 07-SEP-2020: "METALLIC SHINE" WAS MEANT AS METALLIC FRAGMENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10546681 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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
- 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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