MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL Ø9 130° L200 TIMO15; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.943S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional narrative: investigation summary the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the implant shows evidence of manipulation from implantation and removal procedures.The lock prong assembly component was broken the tip.Broken fragment was not returned for evaluation.The observed condition of the device can be consistent with a component failure that was caused by exposure to unintended forces.However, with the information provided is not possible to determine a complete 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 functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the tfna fem nail ø9 130° l200 timo15 would have contributed to the 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.Dimensional inspection: n/a device history manufacturing location: monument manufacturing date: 16-sep-2024 expiration date: 01-sep-2034 part number: 04.037.943s, 9mm/130 deg ti cann tfna 200mm¿ sterile lot number: 34320p5 (sterile) lot quantity: (b)(4) a manufacturing record evaluation was performed for the finished device with batch number 34320p5.No nonconformities or manufacturing irregularities have identified related to the complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿abnormal film was found where the blade head penetrated the hip joint.¿ does not indicate breakage of the nail or any of its components.Therefore, a review of the raw materials would not be pertinent to the reported complaint condition.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) 2025, the patient sustained a motorcycle accident.He hurt his right hip.He could not move his right hip due to pain.Diagnosis, closed displace unstable intertrochanteric fracture of right femur on (b)(6) 2025, surgery performed.Mini-open reduction internal fixation with tfna right hip.The surgery was successful.On (b)(6) 2025, ambulation with walker with partial weight baring right leg.Patient hospital discharge post-operative follow-up: at 1 month: post-operative for 4 weeks, he is doing well with full weight-bearing walking without crutches.At 2 months: post-operative for 2 months, he is doing well with no pain in the right hip.He can walk normally since after the operation and sometimes uses a walker.On (b)(6) 2025, an abnormal film was found where the blade head penetrated the hip joint.The doctor examined the patient, who could walk normally, and found only slight pain around the knee.

• Brand Name: TFNA FEM NAIL Ø9 130° L200 TIMO15
• 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: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22506607
• Report Number: 8030965-2025-07140
• Device Sequence Number: 8652620
• Product Code: HSB
• UDI-Device Identifier: 10886982098030
• UDI-Public: (01)10886982098030(17)340901(10)34320P5
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care 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: 04.037.943S
• Device Lot Number: 34320P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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
• Patient Sex: Unknown