MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD ROTATION KEY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48237056
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while turning the rod, the rotation key and forceps broke.The surgery was completed successfully with alternate tools in the surgery room.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
The initial reporter was updated from physician/surgeon to clinical support employee.
Event or Problem Description
It was reported that while turning the rod, the rotation key and forceps broke.The surgery was completed successfully with alternate tools in the surgery room.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
The product was returned for evaluation and the event was confirmed via visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The plausible root cause of the reported event was determined conclusively to be due to normal wear and tear as the instrument was confirmed to be about 4 years old with no issues found in the manufacturing records.
Event or Problem Description
It was reported that while turning the rod, the rotation key and forceps broke.The surgery was completed successfully with alternate tools in the surgery room.No adverse consequences to the patient were reported.

• Brand Name: XIA 3 TITANIUM ROD ROTATION KEY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7642687
• Report Number: 0009617544-2018-00155
• Device Sequence Number: 19242016
• Product Code: LXH
• UDI-Device Identifier: 07613327265545
• UDI-Public: (01)07613327265545
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2018

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: 48237056
• Device Catalogue Number: 48237056
• Device Lot Number: 143182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 07/11/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 07/05/2018; 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1