MAUDE Adverse Event Report: SYNTHES GMBH STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC; SCREWDRIVER

Catalog Number	03.130.010
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
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.
Event or Problem Description
It was reported that on sep 30, 2025, there were two broken instruments in tray.This occurred prior to a procedure and no patient was involved.The silver probe of the depth gauge broke off.The head of the screw driver was completely stripped and no longer works.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: device history review: manufacturing location: supplier- universal punch / monument, manufacturing date: 01-jul-2020, part number: 03.130.010, stardrive scrwdrvr shft/t4 50mm/self-retaining/hxc, lot number: 36p4866 (non-sterile), lot quantity: (b)(4).Nonconformance noted: n/a.Review of the dhr file: one piece was scrapped in cell at op #40, fnmiscle laser mark, for weigh count-weight variance.Four pieces were scrapped in cell at op #60, vendor tin coat for sample-destructive testing.One piece was scrapped in cell at op #70, incoming inspection ii, for surface finish dings/scratches.Production order traveler met all inspection acceptance criteria apart from the 6 pieces noted.Inspection sheet, incoming inspection, (b)(4) met all inspection acceptance criteria.Packaging label log (pll), (b)(4) was 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 received from universal punch for op # 10 (vendor machine) dated 13-may-2020 was reviewed and determined to be conforming.Hardness specified at hrc 57-60; hardness certified at hrc 58.19.Inspection certificate supplied to universal punch from zapp (for raw material) dated 10-nov-2027 was reviewed and determined to be conforming.Certification of analysis supplied by ionbond for op # 60 (tin coat) dated 11-jun-2020 was reviewed and determined to be conforming.Certificate of compliance supplied by general machine for op #80 (colorize) dated 25-jun-2020 was reviewed and determined to be conforming.A manufacturing record evaluation was performed for the finished device with batch number 36p4866.No nonconformities or manufacturing irregularities have identified related to the complaint condition.A manufacturing record evaluation was performed for the finished device with batch number 36p4866.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.

• Brand Name: STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/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: 23361465
• Report Number: 8030965-2025-10614
• Device Sequence Number: 18346850
• Product Code: HXX
• UDI-Device Identifier: 10886982075192
• UDI-Public: (01)10886982075192(10)36P4866
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup

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: 36P4866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2020
• 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