MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREWDRIVER (EVERYTHING BUT HANDLE); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48231330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the polyaxial shaft broke off when the surgeon was inserting the screw on power using the power adaptor.The scrub tech was able to remove the broken piece from the power adaptor.The surgeon was able to continue and complete the case with another shaft.There was a five minute surgical delay.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.The driver was returned in 2 pieces, with a small piece fractured off the back end of the shaft.The shaft was fractured at the locking indentation.All pieces were retrieved.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Age of the instrument was found to be more than 9 years old.Conclusion: the most likely root cause is wear due to the device's extended use.
Event or Problem Description
It was reported that the polyaxial shaft broke off when the surgeon was inserting the screw on power using the power adaptor.The scrub tech was able to remove the broken piece from the power adaptor.The surgeon was able to continue and complete the case with another shaft.There was a five minute surgical delay.There are no reports of adverse consequences to the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREWDRIVER (EVERYTHING BUT HANDLE)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7329009
• Report Number: 0009617544-2018-00065
• Device Sequence Number: 10916159
• Product Code: LXH
• UDI-Device Identifier: 07613327265408
• UDI-Public: (01)07613327265408
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/21/2018

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: Health Professional
• Device Model Number: 48231330
• Device Catalogue Number: 48231330
• Device Lot Number: 092293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1