NA 03.127.001Recalls & reported problems
Synthes GmbH · 2.8MM FIXED ANGLE DRILL GUIDE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982075017), received between Jun 24, 2021 and Jun 24, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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
- Device-Device Incompatibility6
- Material Twisted/Bent6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, ON AN UNKNOWN PROCEDURE, THE (1) DEPTH GAUGE FOR SMALL SCREWS, (2) PROTECTION SLEEVE/ 11/8, (2) DRILL SLEEVE / 4.2MM, (2) SCREWDRIVER SHAFT SDDRIVE 165MM, (6) 2.8MM FIXED ANGLE DRILL GUIDE, (3) 7.3MM CANNULATED SCREW 32MM THREAD/140MM, (1) SCR RACK 6.5 TI&SS CANN SCRS-16/32 THRDS, (1) LCKNG ATTACH WASHER TRAY RFN-ADVANCED, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/RT-S, AND (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S HAVE AN UNKNOWN ALLEGATION. FIXED ANGLE GUIDES DON'T FIT INTO VA LOCKING HOLES, SCREWS WERE STRIPPED IN PROCESS. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-TWO (22) DEVICES. THIS REPORT IS FOR (1) 2.8MM FIXED ANGLE DRILL GUIDE. THIS REPORT IS 8 OF 13 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12063562 ↗MalfunctionJun 24, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, ON AN UNKNOWN PROCEDURE, THE (1) DEPTH GAUGE FOR SMALL SCREWS, (2) PROTECTION SLEEVE/ 11/8, (2) DRILL SLEEVE / 4.2MM, (2) SCREWDRIVER SHAFT SDDRIVE 165MM, (6) 2.8MM FIXED ANGLE DRILL GUIDE, (3) 7.3MM CANNULATED SCREW 32MM THREAD/140MM, (1) SCR RACK 6.5 TI&SS CANN SCRS-16/32 THRDS, (1) LCKNG ATTACH WASHER TRAY RFN-ADVANCED, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/RT-S, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S HAVE AN UNKNOWN ALLEGATION. FIXED ANGLE GUIDES DON'T FIT INTO VA LOCKING HOLES, SCREWS WERE STRIPPED IN PROCESS. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-TWO (22) DEVICES. THIS REPORT IS FOR (1) 2.8MM FIXED ANGLE DRILL GUIDE. THIS REPORT IS 9 OF 13 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12063560 ↗MalfunctionJun 24, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, ON AN UNKNOWN PROCEDURE, THE (1) DEPTH GAUGE FOR SMALL SCREWS, (2) PROTECTION SLEEVE/ 11/8, (2) DRILL SLEEVE / 4.2MM, (2) SCREWDRIVER SHAFT SDDRIVE 165MM, (6) 2.8MM FIXED ANGLE DRILL GUIDE, (3) 7.3MM CANNULATED SCREW 32MM THREAD/140MM, (1) SCR RACK 6.5 TI&SS CANN SCRS-16/32 THRDS, (1) LCKNG ATTACH WASHER TRAY RFN-ADVANCED, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/RT-S, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S HAVE AN UNKNOWN ALLEGATION. FIXED ANGLE GUIDES DON¿T FIT INTO VA LOCKING HOLES, SCREWS WERE STRIPPED IN PROCESS. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-TWO (22) DEVICES. THIS REPORT IS FOR (1) 2.8MM FIXED ANGLE DRILL GUIDE. THIS REPORT IS 7 OF 13 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12063556 ↗MalfunctionJun 24, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, ON AN UNKNOWN PROCEDURE, THE (1) DEPTH GAUGE FOR SMALL SCREWS, (2) PROTECTION SLEEVE/ 11/8, (2) DRILL SLEEVE / 4.2MM, (2) SCREWDRIVER SHAFT SDDRIVE 165MM, (6) 2.8MM FIXED ANGLE DRILL GUIDE, (3) 7.3MM CANNULATED SCREW 32MM THREAD/140MM, (1) SCR RACK 6.5 TI&SS CANN SCRS-16/32 THRDS, (1) LCKNG ATTACH WASHER TRAY RFN-ADVANCED, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/RT-S, AND (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S HAVE AN UNKNOWN ALLEGATION. FIXED ANGLE GUIDES DON'T FIT INTO VA LOCKING HOLES, SCREWS WERE STRIPPED IN PROCESS. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-TWO (22) DEVICES. THIS REPORT IS FOR (1) 2.8MM FIXED ANGLE DRILL GUIDE. THIS REPORT IS 6 OF 13 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12063359 ↗MalfunctionJun 24, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, ON AN UNKNOWN PROCEDURE, THE (1) DEPTH GAUGE FOR SMALL SCREWS, (2) PROTECTION SLEEVE/ 11/8, (2) DRILL SLEEVE / 4.2MM, (2) SCREWDRIVER SHAFT SDDRIVE 165MM, (6) 2.8MM FIXED ANGLE DRILL GUIDE, (3) 7.3MM CANNULATED SCREW 32MM THREAD/140MM, (1) SCR RACK 6.5 TI&SS CANN SCRS-16/32 THRDS, (1) LCKNG ATTACH WASHER TRAY RFN-ADVANCED, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/RT-S, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S HAVE AN UNKNOWN ALLEGATION. FIXED ANGLE GUIDES DON¿T FIT INTO VA LOCKING HOLES, SCREWS WERE STRIPPED IN PROCESS. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-TWO (22) DEVICES. THIS REPORT IS FOR (1) 2.8MM FIXED ANGLE DRILL GUIDE. THIS REPORT IS 5 OF 13 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12063358 ↗MalfunctionJun 24, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, ON AN UNKNOWN PROCEDURE, THE (1) DEPTH GAUGE FOR SMALL SCREWS, (2) PROTECTION SLEEVE/ 11/8, (2) DRILL SLEEVE / 4.2MM, (2) SCREWDRIVER SHAFT SDDRIVE 165MM, (6) 2.8MM FIXED ANGLE DRILL GUIDE, (3) 7.3MM CANNULATED SCREW 32MM THREAD/140MM, (1) SCR RACK 6.5 TI&SS CANN SCRS-16/32 THRDS, (1) LCKNG ATTACH WASHER TRAY RFN-ADVANCED, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/RT-S, AND (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S HAVE AN UNKNOWN ALLEGATION. FIXED ANGLE GUIDES DON'T FIT INTO VA LOCKING HOLES, SCREWS WERE STRIPPED IN PROCESS. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-TWO (22) DEVICES. THIS REPORT IS FOR (1) 2.8MM FIXED ANGLE DRILL GUIDE. THIS REPORT IS 1 OF 13 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12063343 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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