MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/; GAUGE, DEPTH

Catalog Number 03.010.072

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot part: 03.010.072 lot: 8311058 manufacturing site: (b)(4) release to warehouse date: 19 february 2013.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021 during a retrograde femoral nail procedure, the depth gauge was found to be bent near the tip.The procedure was completed using a depth gauge from another available set.There was no surgical delay.There was no patient consequence.This report is for one (1) depth gauge f/lock-scr meas-range-110 f/.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12657127
• MDR Text Key: 281164588
• Report Number: 8030965-2021-08783
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819760943
• UDI-Public: (01)07611819760943
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.072
• Device Lot Number: 8311058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: RAFN