MAUDE Adverse Event Report: SYNTHES GMBH INTER-LOCK SCREWDRIVER T25/3.5 HEX/224

Model Number	03.010.473
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022 several instruments were broken.No patient involvement was reported.No additional information was reported.This report is for one (1) inter-lock screwdriver t25/3.5 hex/224.This is report 3 of 7 for complaint (b)(4).
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.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
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.H10: additional narrative: d9, e1 h3, h4, h6: part 03.010.473, lot l697089: manufacturing site: (b)(6).Release to warehouse date: (b)(6) 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a service and repair evaluation was completed: the customer reported that 03.010.473, inter-lock screwdriver t25/3.5 hex/224 was broken.The repair technician reported that the tip of the driver is bent, device failed to operate smoothly and cosmetic test was failed.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is damaged component.The evaluation was confirmed.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.

• Brand Name: INTER-LOCK SCREWDRIVER T25/3.5 HEX/224
• 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
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15619782
• Report Number: 8030965-2022-08289
• Device Sequence Number: 6461045
• Product Code: HXX
• UDI-Device Identifier: 10886982068941
• UDI-Public: (01)10886982068941
• Combination Product (Y/N): N
• 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 Model Number: 03.010.473
• Device Catalogue Number: 03.010.473
• Device Lot Number: L697089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2018
• 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: 5.0MM FLEXIBLE SHAFT.; 5.0MM FLEXIBLE SHAFT.; CANNULATED 4.0MM HEXAGONAL SCREWDRIVER.; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS.; INSERTER FOR TI ELASTIC NAILS.; SD SCRDRIVER SFT SD6/SELF-RETAINING/2.0.; TORQUE LIMITER 0.8NM W/AO/ASIF-QC.
• Patient Sex: Unknown