MAUDE Adverse Event Report: DEPUY SPINE INC FINAL TIGHTENER X20; DRIVER

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	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for the spinal fusion with the expedium.The patient had very hard bone and consequently the ball tip feeler were both significantly bent along with the final torque driver was stripped.There was no fragment generated.The surgery was completed successfully.There were no patient consequences are reported.This complaint involves three (3) devices.This report is for (1) unk - plates.This is report 1 of 1 (b)(4).

• Brand Name: FINAL TIGHTENER X20
• Common Device Name: DRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11316048
• Report Number: 1526439-2021-00280
• Device Sequence Number: 2439841
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/11/2021
• Patient Sequence Number: 1