inforMED
MalfunctionHTJ

2.7 VOLT(TM) DEPTH GAUGE 0 TO 60MM

Received Jul 13, 2026 · Event occurred Jan 1, 2026

Report 8030965-2026-07053 · MDR key 25796052

Device

Generic name

Gauge, Depth

Manufacturer

Synthes Gmbh

Catalog number

03.427.060

Product problems

  • Break

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE SCRUB TECH WAS PULLING OUT INSTRUMENTS FOR A CASE AND NOTICED THAT THE DEPTH GAUGE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

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.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.