MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48511906B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the revision driver broke off intra-op.All broken fragments were retrieved.The surgery was completed successfully using back up device.No consequences to the patient was reported.
Additional Manufacturer Narrative
The reported event was confirmed via visual inspection.It was reported that the event occurred when the plate was being removed.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.A manufacturing history review revealed that the screwdriver was approximately 3 years old.Conclusion: the plausible root cause of the reported event was determined to be normal wear and tear due to the age of the instrument.
Event or Problem Description
It was reported that the revision driver broke off intra-op.All broken fragments were retrieved.The surgery was completed successfully using back up device.No consequences to the patient was reported.

• Brand Name: REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8043247
• Report Number: 0009617544-2018-00259
• Device Sequence Number: 1539974
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: 07613327276855
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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 Catalogue Number: 48511906B
• Device Lot Number: 14H025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1