MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY UNI-PLANAR SCREWDRIVER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48041313
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; tip of screw driver broke.
Additional Manufacturer Narrative
Risk assessment; the device was discarded by the customer, so no lot number was provided, nor could visual or functional inspection be performed.Manufacturing record review could not be performed due to no lot number being supplied.With the device not being returned for evaluation, root cause can not be conclusively determined.
Event or Problem Description
It was reported that; tip of screw driver broke.

• Brand Name: XIA DEFORMITY UNI-PLANAR 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: 6067811
• Report Number: 0009617544-2016-00432
• Device Sequence Number: 13605943
• Product Code: LXH
• UDI-Device Identifier: 07613327263237
• UDI-Public: (01)07613327263237
• Combination Product (Y/N): N
• 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): 01/06/2017

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: 48041313
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2016
• Supplement Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1