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

Model Number	48231326
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon had some negative experiences with the screwdriver and the polyaxial closed head screws in a recent surgery.For the closed head polyaxial screw, he experienced a stripped set screw during final tightening.For the screwdriver he experienced stripping and breaking of the t25 torx drive geometry during screw insertion.
Additional Manufacturer Narrative
Method: complaint history review, risk assessment.Result: the customer reported event was confirmed via correspondence.No adverse consequences or surgical delays were reported.The surgeon was informed that the stripping of the iliac screwdriver is a result of high density bone in the ilium in combination with under-sized tapping of the hole.It was recommended to tap closer to size especially with patients with hard bone.The cause is a combination of high density bone with under sized tapping of the screw hole.
Event or Problem Description
It was reported that; surgeon had some negative experiences with the screwdriver and the polyaxial closed head screws in a recent surgery.For the closed head polyaxial screw, he experienced a stripped set screw during final tightening.For the screwdriver he experienced stripping and breaking of the t25 torx drive geometry during screw insertion.

• Brand Name: XIA 3 TITANIUM ILIAC SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7199460
• Report Number: 0009617544-2018-00012
• Device Sequence Number: 11029285
• Product Code: LXH
• UDI-Device Identifier: 07613327265279
• UDI-Public: (01)07613327265279
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/28/2018

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: No Information
• Device Model Number: 48231326
• Device Catalogue Number: 48231326
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1