Peri-Loc 71170660Recalls & reported problems
Smith & Nephew, Inc. · PERI-LOC SMALL FRAGMENT INSTRUMENT & IMPLANT SET LID · Class 1
All models of Peri-Loc (102)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556015933), received between Jul 28, 2020 and May 7, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (3 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 16, 2026.
Most reported problems
Device problems
- Peeled/Delaminated3
- Break1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2021Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS REPORTED THAT DURING SET UP FOR AN INTERNAL FIXATION SURGERY, IT WAS NOTICED THAT THE LID WAS BROKEN AND PEELING. NO PATIENT INJURY WAS REPORTED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11794827 ↗MalfunctionJan 20, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE DEVICE IS PEELING. UNKNOWN WHEN THE INCIDENT OCCURRED, OF OCCURRED A SURGICAL DELAY AND HOW THE PROCEDURE FINISHED. PATIENT INJURIES WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11204269 ↗MalfunctionOct 15, 2020Crack; Crack
IT WAS REPORTED THAT LID IS CRACKING AND PEELING. NO CASE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10687697 ↗MalfunctionJul 28, 2020Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PERI-LOC SMALL FRAGMENT INSTRUMENT & IMPLANT SET LID COATING IS COMING OFF. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10332101 ↗
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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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