MAUDE Adverse Event Report: STRYKER SPINE-US SCREWDRIVER OUTER SLEEVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48268012
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the threads cracked on the outer sleeve of the screwdriver.Could not thread screwdriver into tulip head.There are no reports of adverse consequences to the patient.
Event or Problem Description
It was reported that the threads cracked on the outer sleeve of the screwdriver.Could not thread screwdriver into tulip head.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual analysis, material analysis, device history review, complaint history review, risk assessment; result: the threading on the outer sleeve was found to be fractured.The device was sent for material analysis.The sleeve was found to meet the hardness and elemental constituents specified on the print.No material or manufacturing defects were found.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: a definite root cause cannot be determined, but it is most likely the device was damaged before surgery, either in cleaning or handling as the issue was not found until surgery and it was successfully used before.
Additional Manufacturer Narrative
Method: visual analysis, material analysis, device history review, complaint history review, risk assessment; result: the threading on the outer sleeve was found to be fractured.The device was sent for material analysis.The sleeve was found to meet the hardness and elemental constituents specified on the print.No material or manufacturing defects were found.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: a definite root cause cannot be determined, but it is most likely the device was damaged before surgery, either in cleaning or handling as the issue was not found until surgery and it was successfully used before.
Event or Problem Description
It was reported that the threads cracked on the outer sleeve of the screwdriver.Could not thread screwdriver into tulip head.There are no reports of adverse consequences to the patient.

• Brand Name: SCREWDRIVER OUTER SLEEVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7479161
• Report Number: 0009617544-2018-00099
• Device Sequence Number: 2052801
• Product Code: LXH
• UDI-Device Identifier: 07613327356649
• UDI-Public: (01)07613327356649
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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: Health Professional
• Device Model Number: 48268012
• Device Catalogue Number: 48268012
• Device Lot Number: 177445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1