MAUDE Adverse Event Report: SYNTHES GMBH END-CAP F/TFNA 0; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.045.870S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
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: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 underwent an tfna surgery with the endcaps.After the tfna was fixed, the surgeon removed the device and attempted to insert the endcap (0mm), but it became stuck midway and could not be inserted.The sales rep thought it might be possible that the set screw had not yet been lowered all the way, preventing the endcap from fully inserting.The surgeon tried to retighten the set screw, but the endcap remained stuck in the same position.Another possibility was that a piece of flesh or bone had gotten inside the nail and was interfering with the endcap's threads.After thorough cleaning, the surgeon attempted to insert the endcap again, but it did not go in.The threads on the 0mm end cap appeared to be slightly worn down, so the surgeon decided to issue a new end cap (5mm) and attempt to insert it, but it once again became stuck in the same position and could not be inserted fully.After several attempts, the surgeon was unable to insert it no matter what he did, so the surgeon decided to close the wound without the endcap.The surgery was completed successfully with no delay.In the surgeon's opinion, because the bone was significantly more fragile than usual in this case, bone fragments at the entry point may have gotten inside the nail after the insertion handle was removed, preventing the end cap from fitting into the threads.No further information is available.
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.H.11.Additional narrative: added: d4 (expiration date), d9, d10 and h4.Corrected: d4 (primary udi number).H3, 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 the initial report, a follow-up report 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the cap shows evidence of manipulation from surgical procedure.Threads were also damaged stripped.With damage observed, it is reasonable an issue with correct assembly may be present during usage.Damage of the threads was consistent with a component failure that was caused by exposure to unintended forces most likely caused during intended assembly with mating device.A dimensional inspection was performed to the end-cap diameter and met specifications.The overall complaint was confirmed as the observed condition of the end-cap f/tfna 0 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): a manufacturing record evaluation was performed for the finished device product code: 04.045.870s-15 lot number: 62322p5 it was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 06 may 2025 manufacturing site: jabil bettlach expiry date: 01 apr 2035.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: END-CAP F/TFNA 0
• 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: 22922140
• Report Number: 8030965-2025-08857
• Device Sequence Number: 13350693
• Product Code: HSB
• UDI-Device Identifier: 10886982296054
• UDI-Public: (01)10886982296054(17)350401(10)62322P5
• 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: 62322P5
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 09/10/2025; 09/29/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/11/2025; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: END-CAP F/TFNA 5; END-CAP F/TFNA 5; END-CAP F/TFNA 5; UNK - NAIL HEAD ELEM: TFNA; UNK - NAILS: TFNA
• Patient Sex: Unknown