NA 2598-07-540Recalls & reported problems
Depuy (Ireland) · TISSUE SPARING SOLUTIONS LONG POSTERIOR BROACH HANDLE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295148524), received between May 16, 2019 and Apr 8, 2024 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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
- Device-Device Incompatibility8
- Unintended Movement3
- Device Slipped1
- Material Deformation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
BROACH HANDLE IS LOOSE AFTER CASE. WILL NOT HOLD ONTO BROACHES AT ALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19059267 ↗MalfunctionApr 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT WAS USED DURING SURGERY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16726273 ↗MalfunctionApr 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED. INDICATED, THAT THE INSTRUMENT WAS USED, DURING SURGERY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16726252 ↗MalfunctionApr 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT WAS USED DURING SURGERY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16726231 ↗MalfunctionApr 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT WAS USED DURING SURGERY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16726225 ↗MalfunctionApr 12, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT WAS USED DURING SURGERY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16726171 ↗MalfunctionFeb 2, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED AS NOT LATCHING ONTO BROACHES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13423241 ↗MalfunctionFeb 27, 2020Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN CHECKING ROTATIONAL STABILITY IT WAS DISCOVERED THERE WAS A LOT OF PLAY ON THE BROACH HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9764947 ↗MalfunctionJan 8, 2020Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT WHILE CHECKING THE STABILITY OF THE BROACH, THE SURGEON MENTIONED THAT THE BROACH HANDLE NEEDS REPLACED. NO DEFICIENCY. NORMAL WEAR OVER TIME. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9563962 ↗MalfunctionMay 16, 2019Unintended Movement; Unintended Movement
MDR STAFF INDICATED THAT TWO LONG POSTERIOR BROACH HANDLES (REF # 259807540) HAVE LOOSE CLASPS AND ARE NO LONGER FUNCTIONAL. THESE REQUIRE REPLACEMENT. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8617408 ↗MalfunctionMay 16, 2019Unintended Movement; Unintended Movement
MDR STAFF INDICATED THAT TWO LONG POSTERIOR BROACH HANDLES (REF # 259807540) HAVE LOOSE CLASPS AND ARE NO LONGER FUNCTIONAL. THESE REQUIRE REPLACEMENT. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8617407 ↗
Other BROACH devices
- NA 2598-07-550Depuy (Ireland) · BROACH323 reports
- SUMMIT 2570-00-000Depuy (Ireland) · BROACH269 reports
- NA 952212500FDepuy (Ireland) · BROACH245 reports
- ACTIS 2010-01-050Depuy (Ireland) · BROACH235 reports
- CORAIL 9522-11-500Depuy (Ireland) · BROACH210 reports
- ACTIS 2010-01-060Depuy (Ireland) · BROACH186 reports
- ACTIS 2010-01-040Depuy (Ireland) · BROACH172 reports
- ACTIS 2010-01-070Depuy (Ireland) · BROACH162 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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