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

Catalog Number	48231330
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery screwdriver was not locking properly and felt wobbly, while loading first screw.The screwdriver was not engaging properly while loading the second screw.At the end of procedure, unable to take components of one screwdriver apart.The procedure was completed successfully using back-up device.No adverse consequence to the patient was reported.
Additional Manufacturer Narrative
Correction: lot # corrected to 11a25.Method: visual inspection, functional inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the customer reported event of was not confirmed as the reported complaint could not be duplicated during functional testing.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.A visual inspection was performed and no visual non-conformances were identified.A test screw was loaded onto the fully assembled screwdriver.The screw was tight with no wobble noticed.The screw was driven in and out of a test block with no issues.The device functioned as expected, the reported complaint could not be duplicated.Conclusion: as the reported complaint could not be duplicated during functional testing and the device functioned as expected, a definite root cause cannot be determined.Possible root causes include incorrect alignment, screwdriver not assembled properly, or damaged screw.
Event or Problem Description
It was reported that during surgery screwdriver was not locking properly and felt wobbly, while loading first screw.The screwdriver was not engaging properly while loading the second screw.At the end of procedure, unable to take components of one screwdriver apart.The procedure was completed successfully using back--up device.No adverse consequence to the patient was reported.

• 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: 8097785
• Report Number: 0009617544-2018-00275
• Device Sequence Number: 2307650
• Product Code: LXH
• UDI-Device Identifier: 07613327265408
• UDI-Public: 07613327265408
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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 Catalogue Number: 48231330
• Device Lot Number: 11A255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1