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	06/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during removal of a polyaxial screw, the shank end of the screwdriver broke at the tip.The broken part was lost because of the surgical aspirator.Replacement instrument was available.There are no reports of adverse consequences to the patient.
Event or Problem Description
It was reported that during removal of a polyaxial screw, the shank end of the screwdriver broke at the tip.The broken part was lost because of the surgical aspirator.Replacement instrument was available.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event was confirmed via visual inspection of the returned device.The tip of the inner shaft that interfaces with the screw was completely fractured off.The fractured piece was not returned, but it was confirmed no broken pieces were left in the patient.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Material analysis of the driver determined that the tip was found to have fractured in cleavage due to an applied cantilever force and progressed around the tip in the same mode.The hardness and elemental constituents were consistent with the drawing.No material or manufacturing defects were found.Based on the information provided, the most likely root cause is cantilever force applied to the driver, most likely excessive due to the surgeon having difficulty removing the screw.It is also possible the connection between the screwdriver and screw was inadequate (i.E.Cross threaded), which would cause difficulties removing the screw.
Event or Problem Description
It was reported that during removal of a polyaxial screw, the shank end of the screwdriver broke at the tip.The broken part was lost because of the surgical aspirator.Replacement instrument was available.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Result of material analysis: the observed micro hardness was within the hardness specified in the guidance document.Conclusion correction: based on the information provided, the root caused is applied unidirectional bending force, most likely excessive due to the surgeon having difficulty removing the screw.It is also possible the connection between the screwdriver and screw was inadequate (i.E.Cross threaded), which would cause difficulties removing the screw and cause the user to apply a bending force to the driver to compensate.

• 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: 7687497
• Report Number: 0009617544-2018-00172
• Device Sequence Number: 16373828
• Product Code: LXH
• UDI-Device Identifier: 07613327356656
• UDI-Public: 07613327356656
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2019

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: No Information
• Device Catalogue Number: 48268011
• Device Lot Number: 179262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/29/2018; 01/22/2019
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 09/26/2018; 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1