MAUDE Adverse Event Report: SYNTHES GMBH 9MM/125 DEG TI CANN TFNA 280MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.919S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.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
Device report from japan reports an event as follows: it was reported that on (b)(6) 2023 the patient underwent the primary surgery with the tfna long nail for a femoral subtrochanteric fracture.The surgery was completed successfully with no surgical delay.After the primary surgery, the nail broke.A bha revision was performed on (b)(6) 2023 and completed successfully.The cause of the nail breakage is unknown, no falls occurred.No further information is available.This report is for a 9mm/125 deg ti cann tfna 280mm/left ¿ sterile.This is report 1 of 1 for (b)(4).
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.Manufacturing location: monument, manufacturing date: 10-may-2023, expiration date: 01-may-2033, part number: 04.037.919s, 9mm/125 deg ti cann tfna 280mm/left¿ sterile, lot number: 5957p95 (sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.This lot met all dimensional, visual and sterility criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.2, lock prong, 125 degree tfna lot number: 6137p66 qty 1 / 6137p62 qty (b)(4), lot quantity: (b)(4).Production order travelers met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive lot number: 5837p16 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, ns673827 rev a met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: 5646p54 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 9MM/125 DEG TI CANN TFNA 280MM/LEFT - STERILE
• 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 ave; monument CO
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18382893
• Report Number: 8030965-2023-16025
• Device Sequence Number: 7797304
• Product Code: HSB
• UDI-Device Identifier: 10886982097811
• UDI-Public: (01)10886982097811
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.037.919S
• Device Lot Number: 5957P95
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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: UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown