Arthrex® AR-1927PBRecalls & reported problems
Arthrex, Inc. · PUNCH,FOR CRKSCRW FT&SWVLK ANCHS · Class 1
Data updated Oct 16, 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 00888867023550), received between Jun 7, 2018 and Jun 3, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling 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
- Device Markings/Labelling Problem1
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY IT WAS DISCOVERED THAT THE LASER MARKERS ON THE DEVICE WERE ERASED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25376707 ↗InjuryJun 7, 2018Device Operates Differently Than Expected
IT WAS REPORTED THAT THE PUNCHES FOR SWIVELOCK CORKSCREW, (B)(4), ARE LEAVING BLACK INK SMUDGES OR BLACK DEBRIS IN THE HOLE THAT IS CREATED WHILE PUNCHING. THIS IS OCCURRING MOST NOTABLY ON THE MEDIAL ROW OF THE HUMERUS. IT SEEMS THE PUNCHES ARE NO LONGER BEING ETCHED WITH LASER LINES; INSTEAD WE ARE USING INK FOR THE LASER LINES AND THIS IS RUBBING OFF WHILE PUNCHING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7577722 ↗
Other Accessories, arthroscopic devices
- Arthrex® AR-12990Arthrex, Inc. · Accessories, arthroscopic409 reports
- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
- FIRSTPASS 72290128Smith & Nephew, Inc. · ACCESSORIES,ARTHROSCOPIC232 reports
- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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