MAUDE Adverse Event Report: Synthes GmbH RETENTION PIN FOR SCREWDRIVER SHORT / XL25

Catalog Number	03.045.004
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/1982
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the retention pin was found missing during tray setup.There was no surgical delay.It was noted during manufacturers investigation that the tip was broken off.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H11.Additional manufacturer narrative: h3, h6: per franchise complaint product investigation procedure for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is require.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned device revealed that the tip of the retention pin for scrdriver short / xl25 was broken off.The fragment was not received and no other issues were identified.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces like overtightening the device while assemblance; or by assembling the device in a misaligned position.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.A dimensional inspection for the retention pin for scrdriver short / xl25 was not performed due to post manufacturing damage.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the retention pin for scrdriver short / xl25 would contribute 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 complaint condition.As part of depuy synthes 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.

• Brand Name: RETENTION PIN FOR SCREWDRIVER SHORT / XL25
• Common Device Name: Screwdriver
• Manufacturer (Section D): Synthes GmbH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 50841297
• Report Number: 8030965-2026-09591
• Device Sequence Number: 18651885
• Product Code: HXX
• UDI-Device Identifier: 10886982292513
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: 03.045.004
• Device Lot Number: 5135P66
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown