QUICKSET GRATER HANDLE ASSMB
Received Jun 25, 2026 · Event occurred Jun 5, 2026
Report 1818910-2026-10897 · MDR key 25628146
Device
Generic name
Hip Instruments : Handles
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
244000520
Lot number
A0608
Product problems
- Device-Device Incompatibility
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11: ADDITIONAL MANUFACTURER NARRATIVE: E1: THE REPORTER¿S FACILITY NAME AND ADDRESS WERE NOT PROVIDED. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT THE NEW REAMER HANDLE HAD ALLEGATION. IT WAS REPORTED THAT THE DEVICE DID NOT FIT THE REAMER. THE EVENT DID NOT HAPPEN IN SURGERY.