DJO SURGICAL 804-03-022Recalls & reported problems
Encore Medical, L.P. · DRIVER, 3.5MM POWER HEX RSP · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912147989), received between Apr 25, 2025 and Sep 9, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Mechanical Problem2
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Detachment of Device or Device Component
Patient problems: Foreign Body In Patient
MAUDE report 50681112 ↗InjuryJun 2, 2026Mechanical Problem
REVISION SURGERY DUE TO THE SCREWDRIVER TIP BROKE OFF IN THE BASEPLATE. IT BROKE CLEANLY OFF AND WAS NOT ABOUT TO BE PULLED OUT. THE BASEPLATE HAD TO BE REMOVED WITH PLIERS AND ANOTHER BASEPLATE HAD TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25365925 ↗InjuryApr 25, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
INSTRUMENT FAILURE - USING THIS DRIVER TO PUT IN THE BASEPLATE AND THE TIP OF THE DRIVER BROKE OFF INTO THE IMPLANT, BROKEN FRAGMENTED PIECES LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21915075 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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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