MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL SCREWDRIVER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48268011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was placing a 6.5x40mm screw into the l5 pedicle and the screwdriver was bending at an extreme angle.It snapped in half before the screw was placed into its final position.No adverse consequences to the patient were reported.
Event or Problem Description
Surgeon was placing a 6.5x40mm screw into the l5 pedicle and the screwdriver was bending at an extreme angle.It snapped in half before the screw was placed into its final position.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.The material analysis found shaft was to have fractured at the chamfer area in the smallest diameter section in a mixed mode of cleavage and ductile due to an applied bending load.The elemental constituents were consistent with what is specified on the drawing.The chamfer was observed to not be a sharp corner and is not determined to be the root cause of this fracture.The observed microhardness is not believed to have caused the fracture as the hardness is within the range specified on the guidance document.It was reported that the screwdriver was at an extreme angle in order to work around the thick muscle and fat of the patient.The most likely root cause is the driver fractured due to the bending force applied to it due to the angle of the screw caused by the patient's body type.

• Brand Name: POLYAXIAL SCREWDRIVER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7825292
• Report Number: 0009617544-2018-00209
• Device Sequence Number: 1967216
• Product Code: LXH
• UDI-Device Identifier: 07613327356656
• UDI-Public: 07613327356656
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/26/2018

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: 48268011
• Device Lot Number: 179262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 120