Hip Instruments 01.15.10.0131Recalls & reported problems
Medacta International SA · AMIS Broach Handle without screw · Class 1
All models of Hip Instruments (48)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040768672), received between Jun 19, 2019 and Aug 12, 2019 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Material Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient4
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2019Break; Break
DURING HAMMERING THE BALL SPRING MECHANISM BROKE, THE BALL FELT OUT FROM THE BROACH HANDLE. THE BALL DID NOT FALL IN THE PATIENT. A SECOND INSTRUMENT WAS USED TO COMPLETE THE SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8883094 ↗MalfunctionJul 29, 2019Material Fragmentation; Material Fragmentation
DURING THE SURGERY THE INSTRUMENT BALL SPRING MECHANISM BROKE. NO PARTS FELL IN THE PATIENT, THE SURGERY WAS COMPLETED SUCCESSFULLY USING THE SECOND BROACH HANDLE OF THE INSTRUMENT SET.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8835300 ↗MalfunctionJun 28, 2019Break; Break
DURING SURGERY, WHILE THE SURGEON WAS CHANGING THE BROACH, THE BALL OF THE FIXATION MECHANISM FELL OUT FROM THE HANDLE (NO PATIENT HARM REPORTED). THE BALL WAS DISCARDED AND NOT LEFT IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8744009 ↗MalfunctionJun 26, 2019Break; Break
THE BALL SPRING MECHANISM BROKE OUT. THE BREAKAGE WAS DISCOVERED AFTER THAT THE DEVICE RETURNED TO THE BRANCH. NO ADDITIONAL INFO ABOUT THE DYNAMIC OF THE INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8734826 ↗MalfunctionJun 19, 2019Break; Break
DURING SURGERY THE SPRING AND BALL OF THE INSTRUMENT FELL INTO THE PATIENT'S WOUND. THE SPRING WAS FOUND AND REMOVED WHILE THE BALL REMAINED IN THE PATIENT. NO REVISION SURGERY HAS BEEN PERFORMED AT THE MOMENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8711080 ↗
Other Orthopedic Manual Surgical Instrument devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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