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

Catalog Number	48994000
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 while inserting a screw with the flexible screw driver.The screw driver broke.Surgery was completed successfully.No adverse consequence to the patient was reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed upon visual inspection of the returned device.The screwdriver fractured during screw insertion.The screwdriver was excessively bent back and forth.A material analysis was performed on the similar device with the same failure mode to analyze the fracture and it was concluded that the fracture originated at several points and was caused by fatigue on the instrument.Per dhr history review, the instrument was manufactured in january 2013 and is approximately 6 years old.Conclusion: the plausible root cause of the reported event is fatigue of the instrument over time and normal wear and tear.Bending the instrument back and forth excessively may have also contributed to fracture.
Event or Problem Description
It was reported that while inserting a screw with the flexible screw driver.The screw driver broke.Surgery was completed successfully.No adverse consequence to the patient was reported.

• Brand Name: ANCHOR L SCREWDRIVER MODULAR FLEXIBLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8048304
• Report Number: 0009617544-2018-00260
• Device Sequence Number: 16540753
• Product Code: LXH
• UDI-Device Identifier: 07613327274578
• UDI-Public: 07613327274578
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: 48994000
• Device Lot Number: 12C639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 12/22/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR