DELTA XTEND 2307-90-004Recalls & reported problems
Depuy (Ireland) · DELTA XTEND SCREW GUIDE PIN 1.2 · Class 1
All models of DELTA XTEND (194)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295116530), received between May 28, 2020 and Dec 4, 2025 — classified as 4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Entrapment of Device2
- Component Missing1
- Device-Device Incompatibility1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Break; Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE GLENOSPHERE GUIDE WIRE SNAPPED OFF AND THE SURGEON WAS ABLE TO RETRIEVE IT. FRAGMENTS WERE GENERATED. IT WAS FURTHER REPORTED THAT THE DISTAL PORTION OF A CANNULATED 3.5-MM HEX SCREWDRIVER WAS DAMAGED (CROSS-THREADED AND BENT). THERE WAS TEN-MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23719931 ↗MalfunctionJul 21, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT WHILE INSERTING SCREWS, ONE OF GUIDE PINS BECAME STUCK IN DRILL HOLE. WHILE ATTEMPTING TO REMOVE IT, THE PIN WAS BROKE IN HALF. AFTER AN ATTEMPT TO REMOVE THE PIECE THAT WAS STILL IN THE DRILL HOLE, IT WAS DETERMINED BY THE SURGEON TO PROCEED WITH THE CASE, AS IT WOULD POSE MORE OF AN ISSUE TO CONTINUE TO ATTEMPT TO REMOVE PIN. THE REMAINDER OF THE PIN WAS LEFT IN THE PATIENT AND THE PROCEDURE WAS FINISHED. THE PIN WAS THEN REMOVED ON JULY 1 WITHOUT ANOTHER ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22554246 ↗MalfunctionJan 27, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2025 DURING A RSA SURGERY PERFORMED ON SHOULDER FOR CTA, A PART OF SCREW GUIDE PIN BROKE AND REMAINED INSIDE THE BODY (IN THE BONE). DETAILS WERE AS FOLLOWS. AFTER THE METAGLENN WAS PLACED, A DRILL AND A DRILL GUIDE WERE USED TO CREATE THE PRE-HOLE. THE SCREW GUIDE PIN IN QUESTION WAS PLACED IN THE BONE HOLE AND A LOCKING SCREW WAS INSERTED. THE SURGEON THEN ATTEMPTED TO REMOVE THE SCREW GUIDE PIN IN QUESTION BUT COULD NOT DO SO MANUALLY. THE SCREW GUIDE PIN IN QUESTION COULD NOT BE REMOVED EVEN WITH A PIN REMOVER, IT WAS FINALLY REMOVED BY GRASPING IT WITH THE JACOBS CHUCK OF THE HANDPIECE AND ROTATING IT. HOWEVER, A POSTOPERATIVE X-RAY SHOWED THAT A BROKEN SCREW GUIDE PIN REMAINED AT THE TIP OF THE SCREW. THE SURGEON USED THE IMAGE TO CHECK AT DIFFERENT ANGLES, CONFIRMED THAT THE SCREW GUIDE PIN WAS LIKELY INSIDE THE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 21243654 ↗MalfunctionMay 28, 2020Break; Entrapment of Device; Component Missing; Material Twisted/Bent; Break; Entrapment of Device; Component Missing; Material Twisted/Bent
IT WAS REPORTED THAT SURGEON WAS ON 4TH SCREW WITH SAME GUIDE PIN. GUIDE PIN WENT IN AND SCREW WAS SEATED AND PIN WAS BOUND. USED K. WIRE DRIVER TO REMOVE AND APPROX 1.5 INCH WAS MISSING, TWISTED OFF. USED X-RAY TO SEARCH, LOCATED REMAIN BUT NOT REACHABLE PER DOCTOR. NOTHING FURTHER.
Patient problems: No Code Available; Not Applicable
MAUDE report 10097389 ↗
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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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