inforMED
MalfunctionGAD

HOHMANN RETRACTOR/18MM WIDTH LONG NARROW TIP

Received Jun 11, 2026 · Event occurred Jun 3, 2026

Report 8030965-2026-05837 · MDR key 25469324

Device

Generic name

Retractor

Manufacturer

Synthes Gmbh

Catalog number

399.270

Lot number

3911P94

Product problems

  • Break
  • Entrapment of Device

Patient

68 YR · Female

  • Foreign Body In Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE HOHMANN EXTREMITIES IS BROKEN. THEY TRIED TO REMOVE THE 2MM PARTS, BUT THE FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY.

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.