MAUDE Adverse Event Report: SYNTHES GMBH DRIVE ADAPTOR QC FOR 5.0 SCHANZ SCREWS; DRIVER, SURGICAL, PIN

Catalog Number	393.103
Medical Device Problem Codes	Corroded (1131); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3/h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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 an unknown date, the rust was inspected on devices post operatively due to wear.There were no patient status/ outcome / consequences reported.This report is for one (1) drive adaptor qc for 5.0 schanz screws.This is report 1 of 4 for complaint (b)(4).

• Brand Name: DRIVE ADAPTOR QC FOR 5.0 SCHANZ SCREWS
• Common Device Name: DRIVER, SURGICAL, PIN
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19325643
• Report Number: 8030965-2024-06285
• Device Sequence Number: 12385401
• Product Code: GFC
• UDI-Device Identifier: 10886982199010
• UDI-Public: (01)10886982199010
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 393.103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.0/2.4MM DEPTH GAUGE 50MM; 6.5 STRAIGHT BALL W/O SPIKE 416 LENGTH; 6.5 STRAIGHT BALL W/O SPIKE 416 LENGTH; COMBI T-HANDLE 11 NUT AND 5/6 SCHANZ; COMBI T-HANDLE 11 NUT AND 5/6 SCHANZ; DRIVE ADAPTOR QC FOR 5.0 SCHANZ SCREWS; RATCHET WRENCH-11MM WIDTH ACROSS FLATS; RATCHET WRENCH-11MM WIDTH ACROSS FLATS
• Patient Sex: Unknown