MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE EXTENDED TAB POLYAXIAL DRIVER, 10MM; DRIVER, PROSTHESIS

Model Number	286760010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Awaiting sample: a follow up report will be filed upon completion of the investigation.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
Tip of screwdriver broke off, procedural step is unknown, details has not been provided.
Additional Manufacturer Narrative
Visual examination of the returned found the distal tip was broken.Fracture analysis of the device suggests a quasi-static overload failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the driver tip becoming broken cannot be positively determined.However, the fracture analysis report suggest that the driver underwent a quasi-static overload failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, 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.

• Brand Name: EXTENDED TAB POLYAXIAL DRIVER, 10MM
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6842791
• Report Number: 1526439-2017-10729
• Device Sequence Number: 19032669
• Product Code: HWR
• UDI-Device Identifier: 10705034214887
• UDI-Public: (01)10705034214887
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2017

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: Physician
• Device Model Number: 286760010
• Device Catalogue Number: 286760010
• Device Lot Number: MI19233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 09/21/2017
• Patient Sequence Number: 1