MAUDE Adverse Event Report: SYNTHES GMBH SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM; SCREWDRIVER

Catalog Number	03.019.025
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
After going through the decontamination process, it was noticed that one of the instruments was damaged.This item is a screwdriver for the multiloc humeral nail set.This screwdriver has an insert that goes into the screwdriver and this insert has a cap and that cap has come off and will not stay on.It is unknown when the damage occurred.There was n patient involvement.There was no significant delay.
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.Additional narrative: h3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the end cap is detached from the locking core shaft due to the weld is broken.All parts were returned for inspection.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Properly handling and attention to the approved use of the device diminishes the risk of failure.A functional test was unable to be performed due to the post-manufacturing damage.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the scrdriver f/multiloc scr ø4.5 w/selfhold would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported 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.The drawings reflecting the current and manufactured revisions were reviewed.Device history lot part: 3.019.025-us lot: 808p443 manufacturing site: hägendorf release to warehouse date: 25 august 2022 a manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25232456
• Report Number: 8030965-2026-04778
• Device Sequence Number: 10238009
• Product Code: HXX
• UDI-Device Identifier: 07611819427259
• UDI-Public: (01)07611819427259(10)808P443
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: 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: 03.019.025
• Device Lot Number: 808P443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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