DJO SURGICAL 804-03-008Recalls & reported problems
Encore Medical, L.P. · GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888912147842), received between Feb 9, 2017 and Oct 11, 2024 — classified as 3 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- No Apparent Adverse Event2
- Detachment of Device or Device Component1
- Device Handling Problem1
- Material Integrity Problem1
Patient problems
- Insufficient Information5
- No Known Impact Or Consequence To Patient5
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Information1
- No Patient Involvement1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2024No Apparent Adverse Event; No Apparent Adverse Event
INSTRUMENT FAILURE - WHEN DOCTOR REAMING THE TAP BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20434666 ↗InjuryApr 6, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THERE WAS A 30 MINUTE DELAY IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 19056507 ↗InjuryMay 19, 2023Material Integrity Problem; Material Integrity Problem
REPORTED INCIDENT - 30 MINUTE DELAY IN SURGERY, PART LEFT IN PATIENT.
Patient problems: Insufficient Information
MAUDE report 16969435 ↗MalfunctionDec 14, 2022Device Handling Problem; Device Handling Problem
INSTRUMENT FAILURE: THE TAP BROKE IN HALF INSIDE OF THE BROWN REAMER. PART OF THE BROKEN TAP IS STUCK INSIDE OF THE BROWN REAMER, LEAVING BOTH INSTRUMENTS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15980335 ↗MalfunctionJan 12, 2022Break
INSTRUMENT FAILURE - DUE TO BROKEN INSTRUMENT.
Patient problems: Insufficient Information
MAUDE report 13237925 ↗MalfunctionSep 1, 2021Break
INSTRUMENT FAILURE - TAP BROKE DURING THE CASE IN THE GLENOID.
Patient problems: Insufficient Information
MAUDE report 12410945 ↗MalfunctionApr 8, 2021Break
INSTRUMENT FAILURE - DUE TO DURING THE TAPPING PROCESS, THE TAP SNAPPED OFF INSIDE THE GLENOID. DR. REDIRECTED THE DRILL AND PLACED THE BASEPLATE INFERIOR OF THE BROKEN TAP.
Patient problems: Insufficient Information
MAUDE report 11638426 ↗MalfunctionJul 23, 2020Break
INSTRUMENT FAILURE - SURGEON WAS IN THE PROCESS OF REAMING THE GLENOID AND THE TAP SNAPPED OFF AT THE THREAD. SURGEON WAS ABLE TO REDIRECT AN ALTERNATE TAP AND COMPLETE PROCEDURE. THE REMAINING TAP WAS NOT RETRIEVABLE AND THEREFORE LEFT BEHIND. THE REMAINDER OF THE TAP WILL BE RETURNED TO DJO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10312119 ↗MalfunctionFeb 19, 2020Break
INSTRUMENT FAILURE - THE SURGEON WAS REAMING AND THE TAP SNAPPED WHERE THE THREADS BEGIN. NO PIECE WAS LEFT IN THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 9729343 ↗MalfunctionJun 24, 2019Break
INSTRUMENT FAILURE - THE 6. 5 MM TAP SNAPPED OFF IN GLENOID.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8728698 ↗MalfunctionJun 24, 2019Break
INSTRUMENT FAILURE - TAP BROKE OFF DUE TO SCLEROTIC BONE WHILE REAMING.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8727900 ↗MalfunctionJun 21, 2019Break
PROBLEM - BROKE DURING SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8725113 ↗MalfunctionMar 28, 2019Break
INSTRUMENT FAILURE - THE REVERSE TAP BROKE AT THE DEPTH ETCHING WHILE REAMING. IT WAS BROKEN BELOW THE BONE SO IT WAS LEFT IN AND A NEW HOLE FOR THE BASEPLATE DRILLED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8461571 ↗MalfunctionJan 7, 2019Break; Detachment of Device or Device Component
INSTRUMENT FAILURE - WHILE REAMING THE GLENOID, THE TAB BROKE. PART WAS LEFT IN PATIENT, AND PART DISCARDED.
Patient problems: Foreign Body In Patient
MAUDE report 8222865 ↗MalfunctionJul 23, 2018Break
INSTRUMENT FAILURE - THE SURGEON WAS REAMING THE GLENOID OVER THE TAP, WHEN THE TAP BROKE, LEAVING THE SCREW THREAD PORTION STUCK IN PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7712244 ↗MalfunctionNov 7, 2017Break
INSTRUMENT FAILURE - WHILE THE SURGEON WAS REAMING OVER THE TAP, THE TAP BROKE IN THE GLENOID.
Patient problems: No Information
MAUDE report 7005993 ↗MalfunctionFeb 9, 2017Break
INSTRUMENT FAILURE - THE 6.5 TAP BROKE OFF IN THE PATIENT'S GLENOID HEAD, BUT THE SURGEON WAS ABLE TO GET IT OUT BECAUSE IT WAS FLUSH WITH THE GLENOID. THE SURGEON TOOK A TREPHINE AND DRILLED OVER IT WHICH THEN GRABBED THE GLENOID AND IT CAME OUT. THE SURGEON WAS THEN ABLE TO PUT IMPLANT IN WITHOUT ANY ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6316766 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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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