MAUDE Adverse Event Report: SYNTHES GMBH 10/125 DEG TI CANN TFNA 235/LEFT - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.015S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a depuysynthes sales representative h3, h4, h6: part 04.037.015s, lot 5129p22: manufacturing location: monument.Manufacturing date: march 30, 2023.Expiration date: march 01, 2033.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H3, h6: 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 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 (b)(6) 2024, the patient underwent an open reduction internal fixation (orif) surgery for a femoral trochanteric fracture.The surgeon inserted the nail, lag screw, and injected cement.After that, the surgeon inserted the locking screw and attempted to insert the end cap, but the end cap could not be inserted.The surgeon confirmed that the end cap was inserted in the proper direction, but the end cap could not be engaged with the nail.The surgeon took out the end cap once and checked if the locking mechanism was tightened properly.There was no problem with the locking mechanism.The surgeon used a spare end cap, but the spare end cap could not be properly engaged with the nail either.The surgeon completed the procedure without an end cap.The surgery was completed successfully within a thirty (30) minute delay.The patient status/outcome was reported as stable.This report is for an tfna nail.This is report 2 of 3 for (b)(4).

• Brand Name: 10/125 DEG TI CANN TFNA 235/LEFT - SILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 19470069
• Report Number: 8030965-2024-07120
• Device Sequence Number: 14307261
• Product Code: HSB
• UDI-Device Identifier: 10886982095732
• UDI-Public: 10886982095732
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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: 04.037.015S
• Device Lot Number: 5129P22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA END CAP EXTENS. 0 TAN; TFNA END CAP EXTENS. 0 TAN
• Patient Sex: Unknown