MAUDE Adverse Event Report: Synthes GmbH DRIVING CAP/THREADED; Orthopedic Manual Surgical Instrument

Catalog Number	03.010.523
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
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: h3 h3:h6 the product was returned to depuy synthes for evaluation, and an investigation was conducted in accordance with depuy synthes procedures.Visual inspection of the returned device found the tip was broken apart.Broken fragment was returned attached to mating device insert-handle radioluc fem recon nail.No other anomalies were noted.Surgical technique was reviewed and the following relevant statements were found: to use a hammer, screw the driving cap into the insertion handle and tighten with the ratchet wrench.While applying light blows, monitor the tip of the nail using image intensification.Verify that there is no evidence of impingement distally.Remove the driving cap once the nail has been seated.Notes: using light blows, the hammer can also be used with the driving cap to back slap the nail if the nail has been slightly over inserted.Alternatively, the hammer guide can be attached to the driving cap to facilitate the use of the hammer.Confirm that the driving cap is tightly connected to the insertion handle, as hammering may loosen the connection.Precautions: do not strike the insertion handle directly.The reported complaint was confirmed based on the evaluation results.The investigation traced the potential cause to a component failure that was caused by exposure to unintended forces.Properly handling and attention to the approved use of the device diminishes the risk of failure.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.Device history review = > a manufacturing record evaluation was performed for the finished device product code: 03.010.523 lot number: 21p8078 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 17 feb 2020 manufacturing site: jabil bettlach dhr review retrieved from (b)(4)as the impacted products share the same lot number.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRIVING CAP/THREADED
• Common Device Name: Orthopedic Manual Surgical Instrument
• 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 ; +1(908)386-3534
• MDR Report Key: 50858867
• Report Number: 8030965-2026-09658
• Device Sequence Number: 9953629
• Product Code: LXH
• UDI-Device Identifier: 10886982069351
• UDI-Public: (01)10886982069351
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 03.010.523
• Device Lot Number: 21P8078
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/30/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown