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 Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon broke the draw rod on 2 removal instruments upon trying to remove the screws from the 2 level plate.Surgeon ended up not being able to remove the screws and plate and went on with the surgery.This caused a delay of 5 minutes.
Additional Manufacturer Narrative
Method: visual inspection, product history review, labelling review, complaint history review, nc capa review, risk assessment.Result: it was reported that while attempting to remove a screw for replacement, the tip of the inner shaft fractured.The surgery was completed and all fragments removed.The device was returned for evaluation and the reported event was confirmed via visual inspection.The reflex-hybrid surgical technique warns users that excess pivoting or angulation of the instrument must be avoided to reduce the possibility of bending or breakage of the inner shaft.Also, the revision driver should be axially aligned with the screw trajectory and seated fully into the screw before inserting or tightening the inner shaft.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 most likely root cause is determined to be normal wear and tear due to the age of the instrument.
Event or Problem Description
Surgeon broke the draw rod on 2 removal instruments upon trying to remove the screws from the 2 level plate.Surgeon ended up not being able to remove the screws and plate and went on with the surgery.This caused a delay of 5 minutes.

• 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: 7817285
• Report Number: 0009617544-2018-00207
• Device Sequence Number: 2434050
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: 07613327276855
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/16/2018

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 Catalogue Number: 48511906B
• Device Lot Number: 14H025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1