MAUDE Adverse Event Report: SYNTHES GMBH TURNING HANDLE F/90 SCRWDRVR; SCREWDRIVERS

Catalog Number	03.505.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found holding ring is loose.Therefore assembly with mating device is compromised.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.An interaction between handle for 90 screwdriver and turning handle f/90 scrwdrvr was made and found through many attempts that assembly is intermittently possible due to the condition of the turning handle f/90 scrwdrvr, therefore, the reported condition was able to be replicated.However, no defects were observed on the handle for 90 screwdriver.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the turning handle f/90 scrwdrvr would have contributed 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 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.Dimensional inspection: n/a.Device history lot: part: 03.505.005, lot: 8165481, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 03 feb 2017, expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformance's were identified.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent removal surgery.When it was delivered the day before surgery, it was discovered that the turning handle could not be attached to the handle.It was confirmed that although there were times when it was not possible to attach it, it was not completely impossible to attach it.As a result, additional arrangements were quickly made.There was no impact on the surgery.The surgery was completed successfully without any surgical delay.

• Brand Name: TURNING HANDLE F/90 SCRWDRVR
• Common Device Name: SCREWDRIVERS
• 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: 24377771
• Report Number: 8030965-2026-01609
• Device Sequence Number: 17362245
• Product Code: HXX
• UDI-Device Identifier: 10887587013312
• UDI-Public: (01)10887587013312(10)8165481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082649
• 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: 03.505.005
• Device Lot Number: 8165481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2017
• 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