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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the inner rod of the screwdriver broke.Replacement was available.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Visual inspection, material analysis, product history review, complaint history review, nc/capa history review, labelling review, risk assessment the customer reported event was confirmed via visual inspection.No fragments were left in the patient.The event resulted in a 5 minute surgical delay.Tip of the inner shaft fractured off.The fractured piece was not returned.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Material analysis was performed and device to have fracture mode of cleavage due to an applied bending overload.Elemental composition for the device with the same lot number is consistent with what is specified on the drawing.The probable root cause of the tip fracture is applied bending overload, most likely occurring from the user applying off axis force to the driver.
Event or Problem Description
It was reported that the tip of the inner rod of the screwdriver broke.Replacement was available.There are no reports of adverse consequences to the patient.

• 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: 7926989
• Report Number: 0009617544-2018-00236
• Device Sequence Number: 16522444
• 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
• 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: 11/02/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1