MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL Ø11 LE 130° L235 TIMO15; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.145S

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6).It was reported on an unknown date that the trochanteric fixation nail - advanced (tfna) was broken and revision surgery was necessary.This report is for one (1) 11mm/130 deg ti cann tfna 235mm/left - sterile.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint #
=
> (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter address: (b)(6).Reporter is a (b)(6).(b)(4).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.

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.H6: part 04.037.145s, lot 25p1417: manufacturing location: monument.Manufacturing date: november 14, 2019.Expiration date: november 01, 2029.This lot met all dimensional, visual, sterility, and packaging criteria at the time of release with no issues documented during the inspection or release that would contribute to this complaint condition.H6: a product investigation was completed: visual analysis of the returned sample revealed that the tfna femoral nail has broken in two (2) pieces, the broken fragments were returned.Also, the screws were returned, no defects were found in these devices.No other problem was reported.A dimensional inspection was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.The drawings reflecting the current and manufactured revisions were reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.H11:.

• Brand Name: TFNA FEM NAIL Ø11 LE 130° L235 TIMO15
• Type of Device: 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: 14567495
• MDR Text Key: 293106266
• Report Number: 8030965-2022-03601
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819650534
• UDI-Public: (01)07611819650534
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.145S
• Device Lot Number: 25P1417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2019
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; TFNA SCR PERF L95 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Female