MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROUND HANDLE RATCHET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48231302
Medical Device Problem Code	Mechanical Jam (2983)
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.
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 #: gtin.Method: product inspection, functional inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the customer reported event was confirmed via functional inspection.A visual inspection was performed and no visual non-conformances were identified.The handle was returned jammed onto the screwdriver assembly.Lubricant was applied to the locking collar and the handle was able to be removed once lubricated.The collar was able to lock and unlock easily and was able to be easily attached and detached from the screwdriver.The device functioned as expected after lubrication.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The instruments ifu states "for instruments with articulations, lubrication may be necessary.Using a silicone lubricating cream is recommended." conclusion: as the device was functional after lubrication, the most likely root cause is lack of lubrication.Lack of lubrication can cause the locking collar to jam and this would prevent the handle from disengaging with the screwdriver.

• Brand Name: XIA 3 TITANIUM ROUND HANDLE RATCHET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8097782
• Report Number: 0009617544-2018-00274
• Device Sequence Number: 11328027
• 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: 48231302
• Device Lot Number: 092698
• 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