MAUDE Adverse Event Report: SYNTHES GMBH END CAP FOR TFNA / 0MM STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.045.870S
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
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 medwatch, a follow-up medwatch will be filed as appropriate.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent orif via tfna for femoral trochanteric fracture in the surgery, the procedure proceeded as usual, but when it came time to insert the final end cap, it wouldn't go in, requiring an extra 40 minutes.It was confirmed that the set screw was descending at the step between the straight and bellows sections of the driver.Additional internal rotation, front and side checks, and hand up and down movements were performed, but the product still wouldn't go in.It got stuck several times at an angle.Upon examining the threaded part of the end cap, a long, thin metal fragment, presumably from friction, was found.Also, there were signs of slight crushing in some parts of the thread due to repeated insertion and removal.A new 5mm end cap extension was brought out and tried with that, but that also wouldn't go in.Ultimately, the procedure was completed without inserting the end cap.The surgery was completed successfully with 40 minutes surgical delay.The surgeon commented that it's possible the screw was bent during insertion, causing the threads to jam and resulting in damage.No further information is available.

• Brand Name: END CAP FOR TFNA / 0MM STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25221916
• Report Number: 8030965-2026-04739
• Device Sequence Number: 10001349
• Product Code: HSB
• UDI-Device Identifier: 10886982296054
• UDI-Public: (01)10886982296054(17)351101(10)90813P8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.045.870S
• Device Lot Number: 90813P8
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: 06/05/2026; 06/18/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/08/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2025
• 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