MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RADIUS CROSS CONNECTOR PLUG DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	486619250
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery, the tip of the 2 drivers broke when the surgeon used them to fasten the 20mm cross connector.Finally, the surgeon did not used the connector.
Additional Manufacturer Narrative
Lot# 133907.Visual inspection, device history review, complaint history review, risk assessment.The customer reported event was confirmed via visual insp.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The most likely cause of the reported event was determined to be related to (1) overloading from the user's cantilever force on the tip of the instrument based on the asymmetric damage; (2) normal wear and high frequency usage - the product age of 3+years and sign of wear.
Event or Problem Description
It was reported that; during surgery, the tip of the 2 drivers broke when the surgeon used them to fasten the 20mm cross connector.Finally, the surgeon did not used the connector.

• Brand Name: RADIUS CROSS CONNECTOR PLUG DRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5964935
• Report Number: 0009617544-2016-00370
• Device Sequence Number: 10860592
• Product Code: LXH
• UDI-Device Identifier: 07613327276305
• UDI-Public: (01)07613327276305
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2016

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: 486619250
• Device Lot Number: 133907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1