MAUDE Adverse Event Report: DEPUY SPINE INC MOD T20 POLYAXIAL SCWDRVR; DRIVER, PROSTHESIS

Catalog Number	698326166
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The mod t20 polyaxial screwdriver was received by the customer quality unit.Visual examination of the mod t20 polyaxial screwdriver at the macroscopic level revealed that the fracture was located at the driver¿s distal tip.The fracture analysis reveals plastic deformation at the hex-lobes and torsional shear markings following a circular pattern.This suggests the fractured tip underwent a quasi-static overload torsional shear failure starting at the hex-lobes and extending to the center of the shaft, the potential fracture termination site.Therefore, the reported device failure is confirmed based on the evaluation of the returned device.A device history record review did not find any issues that could have caused or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the mod t20 polyaxial screwdriver fracturing its tip could not be positively determined.However, the fracture analysis report suggests that the fractured tip underwent a quasi-static overload torsional shear failure starting at the hex-lobes and extending to the center of the shaft, the potential fracture termination site.As no issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.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 dr.(b)(6) has custom expedium drivers.He was performing a lumbar fusion that was a revision.He removed the previous screws and was ¿upsizing¿ them.As he was putting in a 7.5x50 screw, the tip of the screw driver broke off in the screw.We removed that screw using a device designed to back out screws.He tried again with the same size screw and broke another driver off into the screw.We removed that one using the same technique.He then tried a different size screw and it worked fine.The case finished as planned and the surgeon was pleased with the outcome.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

• Brand Name: MOD T20 POLYAXIAL SCWDRVR
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8112559
• Report Number: 1526439-2018-51102
• Device Sequence Number: 19262648
• Product Code: HWR
• UDI-Device Identifier: 10705034313009
• UDI-Public: (01)10705034313009
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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: 698326166
• Device Lot Number: GM4325701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1