MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM/2.0MM CRUCIFORM SCRWDRVR SHAFT, SELF-RETAINING; SCREWDRIVER

Catalog Number	313.993
Medical Device Problem Codes	Device Slipped (1584); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: part: 313.993.Lot: 1777p73 manufacturing site: hägendorf release to warehouse date: 29-august-2022.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the tip of the scrdrivershaft-1.5/2 crucif self-holding was stripped.Additionally, the circular tip exhibited deformation, resulting in the loss of its original manufactured geometry.The entire damaged surface was thoroughly examined and no manufacturing-related problems were observed.No other problems were identified.The observed condition of the device is consistent with a component failure that was caused by exposure to unintended forces like overtightening the device while assemblance; or by using the device in a misaligned position.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was not able to be performed due to the mating device was not returned for evaluation.However, the customer¿s allegation can be substantiated, as the observed damage is completely related to the reported malfunction.The overall complaint was confirmed as the observed condition of the scrdrivershaft-1.5/2 crucif self-holding would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure, and 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.The drawings reflecting the current and manufactured revisions were reviewed.
Event or Problem Description
Veterinary complaint.It was reported that on (b)(6) 2025, the products were used for the first time in an orif surgery.The products were purchased on (b)(6) 2025.The sales representative received a report that the fit between the driver tip and screw head was loose, resulting in complete failure of self-holding.The surgeon inserted the product into the appropriate screws and confirmed the fit.With one screwdriver, two 2.0mm cortex screws were inserted five times, successfully grasping them twice (2 out of 10 attempts were successful, and 8 out of 10 attempts were unsuccessful).With another screwdriver, two 2.4mm cortex screws were inserted five times, successfully grasping them eight times (8 out of 10 attempts were successful, and 2 out of 10 attempts were unsuccessful).The surgeon reported that he was unable to grasp them "at all" during the surgery.The surgery was completed successfully with no surgical delay.

• Brand Name: 1.5MM/2.0MM CRUCIFORM SCRWDRVR SHAFT, SELF-RETAINING
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 24429574
• Report Number: 8030965-2026-01838
• Device Sequence Number: 18718095
• Product Code: HXX
• UDI-Device Identifier: 07611819708044
• UDI-Public: (01)07611819708044(10)1777P73
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: 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: 313.993
• Device Lot Number: 1777P73
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• 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