MAUDE Adverse Event Report: Synthes GmbH Retention Pin; Screwdriver

Catalog Number	03.045.008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure, the tip of the short quick anchor retention pin fractured.The fractured fragment remained lodged in the head of the locking screw for the nail.Another screw was used to complete the procedure successfully.It was also noted that a drill bit showed significant wear and loss of sharpness.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: h3, h6: visual inspection of the photo found the device to be broken from the threaded tip.The broken fragment remains stuck on the screw head.No other anomalies were noted.The reported complaint was confirmed based on the evaluation results.The investigation traced the potential cause to a random component failure that may have been caused by exposure to unintended forces.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.H3, h6: for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required.

• Brand Name: Retention Pin
• 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 ; +1(908)386-3534
• MDR Report Key: 50898837
• Report Number: 8030965-2026-09793
• Device Sequence Number: 20333738
• Product Code: HXX
• UDI-Device Identifier: 07612334167859
• UDI-Public: (01)07612334167859(10)427P980
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• 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: 03.045.008
• Device Lot Number: 427P980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2021
• 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