NA 316.236Recalls & reported problems
Synthes GmbH · 1.0MM DRILL BIT STRYKER J-LATCH/60MM · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982189516), received between Aug 6, 2021 and Aug 6, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2021Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2021, DURING OPEN REDUCTION AND INTERNAL FIXATION OF THE SECOND PROXIMAL PHALYNX, THE 1.0MM DRILL BIT BROKE. THE DRILL SHAFT WAS REMOVED EASILY AND THE DRILL TIP WAS RETAINED. THERE WAS A FIVE (5) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.0MM DRILL BIT STRYKER J-LATCH/60MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 12288163 ↗
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- NA 310.21Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY29 reports
- NA 351.27Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY28 reports
- Arthrex® AR-8500OBEArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY27 reports
- Arthrex® AR-8500FOTArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY17 reports
- Arthrex® AR-8150PX-45Arthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY15 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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