MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM POLYAXIAL SCREWDRIVER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48231311
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the screwdriver on the power adapter.The inner polyaxial screwdriver shaft broke.Broke after placement of last screw.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.The device was inspected and it was found the tip of the screwdriver was fractured off.No relevant manufacturing issues were identified as all units met specifications.It is likely that the device fractured due to normal wear and tear.
Event or Problem Description
It was reported that when using the screwdriver on the power adapter.The inner polyaxial screwdriver shaft broke.Broke after placement of last screw.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREWDRIVER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6440526
• Report Number: 0009617544-2017-00114
• Device Sequence Number: 875187
• Product Code: LXH
• UDI-Device Identifier: 07613327265231
• UDI-Public: (01)07613327265231
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: No Information
• Device Catalogue Number: 48231311
• Device Lot Number: 142610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1