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 Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is company representative.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 on an unknown date that during the final tightening of a spine case the t20 expedium 5.5 final tightener was skipped.It was found stripped.The surgery was completed successfully without delay.There were no patient consequences.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This report is for (1) final tightener x20.This report is 1 of 1 for (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: 10173964
• Report Number: 1526439-2020-01209
• Device Sequence Number: 2653087
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2020

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: 06/06/2020
• Initial Report FDA Received Date: 06/19/2020
• Patient Sequence Number: 1