GLOBAL UNITE 2100-70-155Recalls & reported problems
Depuy (Ireland) · GLOBAL UNITE FEMALE HEX DRIVER SIZE 4.0 · Class 1
All models of GLOBAL UNITE (91)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Global Unite female hex screwdriver is a surgical instrument used to tighten implant parts. The 34 reports mostly describe the tool cracking or breaking during use, sometimes stripping so it stops tightening, and bending or wearing out with normal handling. No deaths were reported and 2 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295085959), received between Oct 5, 2017 and Jun 24, 2025 — classified as 2 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Crack” (16 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
- Crack16
- Break11
- Material Twisted/Bent4
- Naturally Worn3
- Device-Device Incompatibility2
- Insufficient Device Problem Information2
- Appropriate Device Problem Term/Code Not Available1
- Mechanical Problem1
Patient problems
- No Consequences Or Impact To Patient16
- No Clinical Signs, Symptoms or Conditions11
- Not Applicable4
- Insufficient Information2
- No Information2
- No Code Available1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT BROKEN SCREWDRIVER DISCOVERED BY SPD. THERE WAS NO IMPACT ON CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22320298 ↗MalfunctionFeb 27, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SCREW DRIVER WAS STRIPPED AND NOT TIGHTENING PRODUCTS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16443335 ↗MalfunctionJan 31, 2023Break; Crack; Break; Crack
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE INSTRUMENT DID NOT SPLIT INTO 2, THERE WAS NO DEBRIS AND YES IT CAN BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16271748 ↗MalfunctionDec 27, 2022Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCRUB TECH WAS ASSEMBLING TRIAL PROXIMAL BODY TO STEM WHEN THE TIP OF 3.5 MALE HEX DRIVER SLIPPED OFF THE ASSEMBLY NUT. IT WAS NOTICED THAT THE TIP OF THE DRIVER WAS CRACKED. ANOTHER 3.5 MALE HEX NUT DRIVE WAS OPENED AND ASSEMBLY WAS DONE. NO DELAY WAS THERE. RECEIVED ADDITIONAL INFORMATION THROUGH EMAIL FROM (B)(6) ON (B)(6) 2022 STATING: A)THERE WERE NO SEPARATE PIECES, AND B) I PROVIDED THE WRONG PART NUMBER. IT SHOULD HAVE BEEN 2100-70-155 4.0 FEMALE HEX SCREWDRIVER. WRONG PART NUMBER IS LISTED ON THE SHOULDER XPERT APP ON THE REVISION TRAY. THE LOT NUMBER IS CORRECT FOR THIS CATALOG NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16052098 ↗MalfunctionDec 1, 2022Break; Break
SCREWDRIVER HEAD BROKE OPEN WHEN BEING USED. THE ROUND FEMALE END BROKE OPEN. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15894599 ↗MalfunctionSep 12, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SCREWDRIVER IS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15406060 ↗MalfunctionJan 20, 2022Crack; Crack
SCREWDRIVER FROM THE UNITE COMMON TRAY HAD A CRACK AT THE VERY END. NO SURGICAL DELAY OR ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13310946 ↗MalfunctionSep 10, 2021Naturally Worn; Naturally Worn
(B)(4). IT WAS REPORTED THAT THE GREEN SCREWDRIVER STRIPPED DURING NORMAL USE. (B)(6): PLEASE REPLACE TO THE (B)(6) OFFICE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12453429 ↗MalfunctionAug 24, 2021Crack; Crack
IT WAS REPORTED THAT THE HEX SCREWDRIVER CRACKED IN TWO PLACES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12358086 ↗MalfunctionJun 25, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY PLAN TO CONVERT A GLOBAL UNITE PROXIMAL BODY TO AN EPIPHYSIS FOR A REVERSE SHOULDER ARTHROPLASTY. SURGEON WAS UNABLE TO "UNSCREW" THE PROXIMAL BODY FROM THE STEM. THE STEM/BODY CONSTRUCT WAS IMPLANTED IN THE PATIENT. THE SURGEON ENDED UP REMOVING THE ENTIRE STEM/BODY CONSTRUCT. TWO HEX SCREWDRIVERS WERE BROKEN TRYING TO REMOVE SCREW. A SURGICAL DELAY OF 30 MINUTES WAS ALSO REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT SHOULDER.
Patient problems: Insufficient Information
MAUDE report 12065516 ↗MalfunctionJun 25, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY PLAN TO CONVERT A GLOBAL UNITE PROXIMAL BODY TO AN EPIPHYSIS FOR A REVERSE SHOULDER ARTHROPLASTY. SURGEON WAS UNABLE TO "UNSCREW" THE PROXIMAL BODY FROM THE STEM. THE STEM/BODY CONSTRUCT WAS IMPLANTED IN THE PATIENT. THE SURGEON ENDED UP REMOVING THE ENTIRE STEM/BODY CONSTRUCT. TWO HEX SCREWDRIVERS WERE BROKEN TRYING TO REMOVE SCREW. A SURGICAL DELAY OF 30 MINUTES WAS ALSO REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2021. RIGHT SHOULDER.
Patient problems: Insufficient Information
MAUDE report 12065515 ↗MalfunctionFeb 2, 2021Crack; Crack
IT WAS REPORTED THAT THE SCREW DRIVER ( GREEN GLOBAL UNITE ) WAS FOUND WITH A CRACK WHILE CLEANING OF TRAYS. IT DID NOT AFFECT ANY CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11267861 ↗MalfunctionNov 17, 2020Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE FEMALE PART OF THE SCREWDRIVER HAD A CRACK IN IT. IT WON¿T ALLOW THE PROXIMAL BODY TO TIGHTEN DOWN ON THE STEM. THERE WAS NO DELAY IN THE SURGERY, NOTHING WAS LEFT IN THE PATIENT. JUST NEED A NEW ONE BACK ASAP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10854266 ↗MalfunctionSep 11, 2020Break; Break
DURING CONVERSION GLOBAL UNITE ¿ TO (B)(6), THE TOP SCREW IN THE EPIPHYSIS WAS VERY TIGHT, THE DRIVER BROKE.
Patient problems: No Code Available
MAUDE report 10522200 ↗MalfunctionMar 23, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE 4.0MM GREEN DRIVER WAS ¿STRIPPED¿ ACCORDING TO SURGEON CUSTOMER. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9866273 ↗MalfunctionAug 2, 2019Crack; Crack
IT WAS REPORTED THAT THE 2100-70-155 FEMALE HEX SCREWDRIVER DISCOVERED AS CRACKED WHEN THE TRAY WAS RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8855577 ↗MalfunctionJul 29, 2019Crack; Crack
IT WAS REPORTED THAT THE SCREW DRIVER TIP SPLIT AFTER STEM WAS PUT TOGETHER, DID NOT SLOW DOWN THE CASE, NOTICED THE SPLIT WHEN RESETTING INSTRUMENTS. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8836115 ↗MalfunctionJun 11, 2019Break; Break
IT WAS REPORTED THAT WHILE CONVERTING A GLOBAL UNITE TO A REVERSE , THEY NOTICED THAT THE UNITE PROXIMAL BODY WAS COLD WELDED AND 2 SCREW DRIVERS WERE BROKEN TRYING TO GET IT APART . THE REVERSE SCREW DRIVER WAS DAMAGED TRYING WHILE INSERTING THE LOCKING SCREW. THIS MDR INCLUDES THE IMPLANTS THAT WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2019. UNKNOWN SHOULDER.
Patient problems: Not Applicable
MAUDE report 8687898 ↗MalfunctionJun 11, 2019Break; Break
IT WAS REPORTED THAT WHILE CONVERTING A GLOBAL UNITE TO A REVERSE , THEY NOTICED THAT THE UNITE PROXIMAL BODY WAS COLD WELDED AND 2 SCREW DRIVERS WERE BROKEN TRYING TO GET IT APART . THE REVERSE SCREW DRIVER WAS DAMAGED TRYING WHILE INSERTING THE LOCKING SCREW. THIS MDR INCLUDES THE IMPLANTS THAT WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2019; UNKNOWN SHOULDER.
Patient problems: Not Applicable
MAUDE report 8687896 ↗MalfunctionMay 2, 2019Crack; Material Twisted/Bent; Crack; Material Twisted/Bent
IT WAS REPORTED THAT THE TIP DRIVE WAS CRACKED AND STRIPPED WHEN ATTEMPTING TO TAKE OUT SCREWS IN A TSA REVISION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8573843 ↗MalfunctionMay 2, 2019Crack; Material Twisted/Bent; Crack; Material Twisted/Bent
IT WAS REPORTED THAT THE TIP DRIVE WAS CRACKED AND STRIPPED WHEN ATTEMPTING TO TAKE OUT SCREWS IN A TSA REVISION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8573840 ↗MalfunctionFeb 20, 2019Crack; Material Twisted/Bent; Crack; Material Twisted/Bent
IT WAS REPORTED THAT THE HEX END OF THE DRIVER WAS CRACKED AND ALSO BENT OUTWARDS. THIS DID NOT OCCUR DURING SURGERY. THIS HEX DRIVER WAS OUT OF GLOBAL UNITE REVISION SET 01. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8355364 ↗MalfunctionJan 28, 2019Crack; Crack
IT WAS REPORTED THAT THE TIP OF GREEN SCREW DRIVER CRACKED WHEN TIGHTENING PROXIMAL BODY DISTAL STEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8281179 ↗MalfunctionJan 22, 2019Crack; Crack
SCREWDRIVER CRACKED WHEN TIGHTENING PROXIMAL BODY TO DISTAL STEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8267327 ↗MalfunctionOct 31, 2018Crack; Crack
IT WAS REPORTED THAT THE TIP OF THE GREEN SCREW DRIVER WAS CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8023519 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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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