MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR F/NAILS Ø5 L 34 XL25; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.045.034TS
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent osteosynthesis surgery for trochanteric femoral fracture with the locking screw.The surgeon used the locking screw for the surgery via tfna, however due to a poor fit and wobbly driver with the locking screw, the locking screw did not enter the hole after pre-drilling and slid through the bone, causing aberrant the locking screw to enter the body.The incision was enlarged, and the errant parts were removed.The provided product was used instead, and the surgery was completed successfully with no delay.No further information is available.
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.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: corrected: e1 (initial reporter first name, last name) if information is obtained that was not available for the initial 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11.Additional narrative: h3, h6: the product was returned to depuy synthes for evaluation.The screw was not returned in its original packaging.The laser marking on the screw matches with the batch number# 26155p7 referred in the complaint description.Traces of usage are clearly visible on the screw head and specifically within the drive.A handling test with the returned screw and with the corresponding xl25 screwdriver # 03.045.001 and the retention pin # 03.045.002 was performed at the sustaining engineering department in jnj zuchwill.The screwdriver and retention pin did perfectly fit the screw.The screw remained secured assembled with the screwdriver.The reported complaint condition cannot be replicated.All critical to quality features and inspection features which could contribute to the complaint condition were inspected and found in specification.All dimensional features which could contribute to the complaint condition were inspected and found within specification.The complaint condition could not be replicated during the performed functional test.Additionally, within the performed dhr review, there is no indication of a deviation in the manufacturing process which could lead to the complaint condition.Therefore, the reported complaint condition cannot be confirmed.The overall complaint was not confirmed as the observed condition of the lockscr f/nails ø5 l 34 xl25 would not have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through j&j medtech orthopedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the finished device.Product code: 04.045.034ts.Lot number: 26155p7.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 05 aug 2024.Manufacturing site: jabil grenchen.Expiry date: 01 jul 2029.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LOCKSCR F/NAILS Ø5 L 34 XL25
• 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: 22214602
• Report Number: 8030965-2025-06006
• Device Sequence Number: 12926647
• Product Code: HSB
• UDI-Device Identifier: 10886982302649
• UDI-Public: (01)10886982302649(17)290701(10)26155P7
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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: 04.045.034TS
• Device Lot Number: 26155P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 11/14/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/16/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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