MAUDE Adverse Event Report: SYNTHES GMBH SD SCRWDRVR SHFT/T4 50/SELF-RETAIN/HXC; SCREWDRIVER

Catalog Number	03.130.010
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2026
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.Additional narrative: h6: photo investigation: the product was not returned to depuy synthes; however, photos were provided for review.The photo investigation revealed that scrdriver shaft 1.3/1.5 t4 self-holding had stripped.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the scrdriver shaft 1.3/1.5 t4 self-holding] would contribute to the complained device issue.Based on the investigation findings, potential cause attributed 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 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.H3, h4, h6: device history record (dhr) review conducted: manufacturing location: supplier- mark-two / monument manufacturing date: 19-aug-2020 part number: 03.130.010, stardrive scrwdrvr shft/t4 50mm/self-retaining/hxc lot number: 43p7201 (non-sterile) lot quantity: (b)(4) nonconformance noted: n/a review of the dhr file: two pieces were scrapped in cell, laser mark, for laser etch-position.Four pieces were scrapped in cell, vendor tin coat, for assembly-incorrectly assembled.Production order traveler met all inspection acceptance criteria apart from the 6 pieces scrapped.Inspection sheet, incoming inspection i, incoming inspection ii, incoming final inspection, met all inspection acceptance criteria.Packaging label log (pll), lppf rev c and lmd rev a were reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Certificate of compliance dated 16-jun-2020 was reviewed and determined to be conforming.Inspection certificate dated 16-jun-2020 was reviewed and determined to be conforming.Certificate of analysis dated 28-jun-2020 was reviewed and determined to be conforming.Certificate of compliance dated 13-aug-2020 was reviewed and determined to be conforming.A manufacturing record evaluation was performed for the finished device with batch number 43p7201.No nonconformities or manufacturing irregularities have identified related to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the surgeon reports that t4 screwdrivers in the va hand set were stripped and do not lock into the head of the screw.There was no surgical delay due to the reported event.The procedure was successfully completed and no fragments were generated.There was no patient consequence.

• Brand Name: SD SCRWDRVR SHFT/T4 50/SELF-RETAIN/HXC
• 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 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25657570
• Report Number: 8030965-2026-06709
• Device Sequence Number: 18491558
• Product Code: HXX
• UDI-Device Identifier: 10886982075192
• UDI-Public: (01)10886982075192(10)43P7201
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 03.130.010
• Device Lot Number: 43P7201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown