MAUDE Adverse Event Report: SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 360MM/RIGHT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.256S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
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.H11 additional narrative: added: d9 and d10.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 the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a hip surgery, the 12/130 deg ti cann tfna 360/right-sile broke upon attempted removal from the patient.Appropriate instrumentation was used to remove broken hardware (distal portion of tfna nail).There was a surgical delay of 10 minutes.The procedure was completed successfully.There were no patient consequences.
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.Corrected: e1 (facility name).H3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed that the 12/130 deg ti cann tfna 360/right-sile was found broken in two parts across the proximal locking hole.The broken fragment was returned for examination and the fracture surface was examined, and irregular areas in the from of beach marks were observed, indicating fatigue.Other section of the fracture suggest that the implant was exposed to stress causing the rupture of the implant.Therefore, based on this evidence it is reasonable to conclude that the fracture was caused in two events the first were the implant underwent a high cycle fatigue, and the second high stress.There is no indication of damage related to material issues was observed.Additionally, it was observed with signs of scratches and wear which could have been due to implantation and extraction process.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection was unable to be performed due to post manufacturing process.A functional evaluation was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the 12/130 deg ti cann tfna 360/right-sile would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): manufacturing location: monument, manufacturing date: 09-oct-2019, expiration date: 31-aug-2029, part number: 04.037.256s, 12mm/130 deg ti cann tfna 360mm/right- sterile, lot number: 17p8613 (sterile), lot quantity: (b)(4).A manufacturing record evaluation was performed for the finished device with batch number 17p8613.No nonconformities or manufacturing irregularities have identified related to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12MM/130 DEG TI CANN TFNA 360MM/RIGHT-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21898560
• Report Number: 8030965-2025-03984
• Device Sequence Number: 8082636
• Product Code: HSB
• UDI-Device Identifier: 10886982097361
• UDI-Public: (01)10886982097361(17)290831(10)17P8613
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• 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: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.037.256S
• Device Lot Number: 17P8613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 05/20/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 04/28/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA HELICAL BLADE PERF L105 TAN.; UNK - NAIL HEAD ELEM: TFNA SCREW.
• Patient Sex: Unknown