MAUDE Adverse Event Report: SYNTHES GMBH 9/125 DEG TI CANN TFNA 235/LEFT - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.915S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/12/2023
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 expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).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 synthes reports an event in france as follows: it was reported that the patient was previously operated on for a femoral lengthening osteotomy on a nail in the case of right constitutional shortening aggravated by a leg fracture resulting in associated loss of height.On the left, a subtrochanteric osteotomy of the femur was performed in order to gain further inequality on (b)(6) 2022.Unfortunately, the patient suffered an exceptional complication with the locking nail used.This involved a small nail that fractured at the locking screw hole.This complication occurred when the patient was not applying pressure.The patient was very rigorous and did not make any abnormal or uncontrolled gestures.The pain appeared on (b)(6) 2023 in the morning when got up without making any particular effort or pressing down.This nail rupture led to complications and delayed consolidation, justifying decortication and the insertion of a neutralisation plate with resection of the anterior hypertrophic bone callus.This report involves one (1) 9mm/125 deg ti cann tfna 235mm/left - sterile.This is report 1 of 1 for (b)(4).This complaint is related to (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that 9/125 deg ti cann tfna 235/left ¿ sile is found broken from the distal end.No other finding is seen a dimensional inspection was not performed for the 9/125 deg ti cann tfna 235/left ¿ sile 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 unintended forces.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 of the 9/125 deg ti cann tfna 235/left ¿ sile 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.H3, h6: device history record (dhr) review conducted: manufacturing location: monument manufacturing date: 26-may-2021 expiration date: 01-may-2031 part number: 04.037.043s, 10mm/130 deg ti cann tfna 200mm ¿ sterile lot number: 182p856 (sterile) lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, in process / inspect dimensional / final, met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, met all inspection acceptance criteria.Packaging label log (pll) lmd rev ad was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn was reviewed and determined to be conforming.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.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive lot number: 98p9746 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended lot number: 77p1349 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card dated 15-jan-2021 were reviewed and determined to be conforming.Part number: 04.037.942.2, lock prong, 130 degree, tfna lot number: 91p1019 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, final inspection, met all inspection acceptance criteria.Part number: 21127, timoagri16.00 bp80 lot number: 60p0829 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certified test report dated 13-apr-2020 was reviewed and determined to be conforming.Lot summary report dated 15-jun-2020 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.

• Brand Name: 9/125 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: 17904671
• Report Number: 8030965-2023-12786
• Device Sequence Number: 18028078
• Product Code: HSB
• UDI-Device Identifier: 10886982097774
• UDI-Public: 10886982097774
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.037.915S
• Device Lot Number: 174P155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 12/01/2023; 01/26/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/22/2023; 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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: NAIL LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown