MAUDE Adverse Event Report: SYNTHES GMBH DRIVER F/NUT; SCREWDRIVER

Catalog Number	03.045.033
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The product damage documented has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.No further information can be obtained as the case was not reported by the customer.
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, 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.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that driver f/nut was received connected with the protect sleeve 13 f/expert r/afn retrogr.The prongs of driver f/nut were observed damaged/deformed, the shaft showed several scratches and the blue handle is damage and broken in a section.The fragments were not received.This type of damage is consistent with other tools and hard edges coming in contact with the device and combination with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection for the driver f/nut was not performed due to post manufacturing damage.A functional test was performed to try to disassemble the devices, but it was not possible as they remained stuck.Per the frn-advanced femoral recon nailing system (frna) surgical technique guidw.Part number 03.045.033 driver for nut is compatible with the part number 03.045.003 screwdriver, short, xl25 and part number 03.045.004 retention pin for screwdriver, short.In conclusion, the part number 03.045.033 driver f/nut is not compatible with the part number 03.010.502 protection sleeve 13.0 for expert r/afn, retrograde.The observed condition of the device is consistent with an incorrect use of the device due to incompatibility according to surgical technique.The overall complaint was confirmed as the observed condition of the driver f/nut would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 part number: 03.045.033.Lot number: 137p274.Manufacturing site: hägendorf.Release to warehouse date: 15-june-2021.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRIVER F/NUT
• Common Device Name: SCREWDRIVER
• 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: 22500599
• Report Number: 8030965-2025-07117
• Device Sequence Number: 7028934
• Product Code: HXX
• UDI-Device Identifier: 10886982296153
• UDI-Public: (01)10886982296153(10)137P274
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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

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: 03.045.033
• Device Lot Number: 137P274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown