MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR LARGE EXTERNAL FIXATOR; GAUGE, DEPTH

Catalog Number	393.78
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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 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 or Problem Description
It was reported that on an unknown date, an event occurred where suprapatellar tibial nailing was done.During insertion and distal interlocking the nail, the nail was backslapped.Surgeon back slapped fracture malreduced and rotated the insertion handle.While rotating the insertion handle, the connection to the nail loosened.Surgeon wanted the connecting screw and insertion handle to be replaced.Depth gauge was also bent.Blue handle did not connect to power for some reason.There was 5 minutes surgical delay.It is unknown if the procedure was completed successfully.There was no patient consequences.This report is for one (1)depth gauge for large external fixator this is report 4 of 4 for complaint (b)(4).

• Brand Name: DEPTH GAUGE FOR LARGE EXTERNAL FIXATOR
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17671135
• Report Number: 8030965-2023-11120
• Device Sequence Number: 6994126
• Product Code: HTJ
• UDI-Device Identifier: 10886982199447
• UDI-Public: (01)10886982199447
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 393.78
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONNECTING SCREW/ CANNULATED LONG; HAND LRG CANN W/QUICK-COUPL HEX12; INSERTION HANDLE/ RADIOLUCENT LONG; UNK - NAILS: TIBIAL
• Patient Sex: Unknown