MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C SCREWDRIVER - FLEXIBLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48328550
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the flexible driver bent during screw insertion.The device is still intact there were no broken fragments.Upon inspection of the returned device, the flexible shaft was found to be fractured.No adverse consequences to the patient was reported.This complaint will be reported as device malfunction.
Additional Manufacturer Narrative
Visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment the reported issue was confirmed upon visual inspection.The device surgical technique warns against excessively bending the flexible screwdriver back and forth; bending the shaft to the full limit repeatedly may result in fracture.There is a picture in the surgical technique indicating the bending limits of the flexible screwdriver (do not bend past approximately 35 degrees).It was reported that the insertion angle was difficult and the screwdriver was excessively bended back and forth.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.This device was manufactured approximately 5 years ago.The plausible root cause of the reported event is bending the screwdriver past its limitation due to difficult insertion angle and normal wear and tear of the instrument.
Event or Problem Description
It was reported that the flexible driver bent during screw insertion.The device is still intact there were no broken fragments.Upon inspection of the returned device, the flexible shaft was found to be fractured.No adverse consequences to the patient was reported.This complaint will be reported as device malfunction.

• Brand Name: ANCHOR C SCREWDRIVER - FLEXIBLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7987049
• Report Number: 0009617544-2018-00245
• Device Sequence Number: 1531179
• Product Code: LXH
• UDI-Device Identifier: 07613327126273
• UDI-Public: 07613327126273
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 12/21/2018

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: 48328550
• Device Lot Number: 13D189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1