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

Model Number	48511906B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during initial implantation, the surgeon wanted to reposition a screw.The surgeon attached the screwdriver on the screw, started to rotate and the tip of the inner sheath broke.The tip remains in the head of the screw.There are no adverse health consequences to the patient.
Additional Manufacturer Narrative
Result: device was confirmed to have its tip fractured as reported.The device was returned for evaluation and the reported event was confirmed via visual inspection.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 is approximately 7 years old.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 during initial implantation, the surgeon wanted to reposition a screw.The surgeon attached the screwdriver on the screw, started to rotate and the tip of the inner sheath broke.The tip remains in the head of the screw.There are no adverse health consequences to the patient.

• 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: 7558676
• Report Number: 0009617544-2018-00118
• Device Sequence Number: 13948001
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: (01)07613327276855
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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: 48511906B
• Device Catalogue Number: 48511906B
• Device Lot Number: 119317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1