MAUDE Adverse Event Report: DEPUY SPINE INC. FINAL TIGHTENER X20; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR, REUSABLE

Model Number	286210130
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in (b)(6) as follows: this is report 1 of 3 for (b)(4).It was reported by the customer in (b)(6) that during a spinal fusion procedure on (b)(6) 2022, the surgeon was performing final tightening on an expedium 4.5 set screw and he stripped both final torque devices at the distal end tip.According to the report, the surgeon was able to complete the case with the least damaged driver which also had stripped threads at the distal end tip.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.This complaint involves three (3) devices.
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.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 preventive 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.

• Brand Name: FINAL TIGHTENER X20
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR, REUSABLE
• Manufacturer (Section D): DEPUY SPINE INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14374039
• Report Number: 1526439-2022-00695
• Device Sequence Number: 17584867
• Product Code: HWR
• UDI-Device Identifier: 10705034211121
• UDI-Public: 10705034211121
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,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 Model Number: 286210130
• Device Catalogue Number: 286210130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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