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

Model Number	48231326
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that too much torque was applied to closed head iliac screwdrivers.There are no reports of adverse health consequences.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via visual inspection.2 outer sleeves were returned for lot 141256.No issue was found with one outer sleeve.The other outer sleeve had fractured threading.The fractured piece was not returned.The inner shaft returned had a fractured tip and the threading was deformed.Manufacturing history was reviewed and no issues were identified.Conclusion: according to similar material analysis and the event description, the most likely root cause is excessive force was applied to the driver causing it to fracture and deform.It is possible improper screw hole preparation, hard bone quality, under tapping, or misalignment of the driver to the screw contributed to the event.
Event or Problem Description
It was reported that too much torque was applied to closed head iliac screwdrivers.There are no reports of adverse health consequences.

• Brand Name: XIA 3 TITANIUM ILIAC SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7342444
• Report Number: 0009617544-2018-00066
• Device Sequence Number: 10773054
• Product Code: LXH
• UDI-Device Identifier: 07613327265279
• UDI-Public: (01)07613327265279
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: 141256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1