MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR QUICK TURN SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48770820
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tip of the screwdriver broke off when the surgeon was unlocking the locking mechanism.Fragment from the broken screwdriver remains in the patient.No adverse consequence to the patient and surgery was completed successfully.
Event or Problem Description
It was reported the tip of the screwdriver broke off when the surgeon was unlocking the locking mechanism.Fragment from the broken screwdriver remains in the patient.No adverse consequence to the patient and surgery was completed successfully.
Additional Manufacturer Narrative
Functional inspection could not be performed due to fracture, the driver is no longer functional.Complaint history records were reviewed for the lot number provided and no similar events were identified.Manufacturing history records were reviewed for the lot number provided and no relevant manufacturing issues were identified.It was reported that the event occurred during locking the spring bar on the plate and resulted in a 5 minute delay to try and retrieve the broken fragment which remained implanted in the patient.Procedure completed successfully with another instrument.Per the surgical technique: "a solid screwdriver for rotating the blocker is recommended, however, the quick turn screwdriver can also be used." the probable root cause of the tip deformation is the age and usage of the instrument.

• Brand Name: AVIATOR QUICK TURN SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8707461
• Report Number: 0009617544-2019-00079
• Device Sequence Number: 2004288
• Product Code: LXH
• UDI-Device Identifier: 07613327273045
• UDI-Public: 07613327273045
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 48770820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1