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

Catalog Number	486619250
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the surgeon used plug driver in order to tighten plug of the connector.When the surgeon tightened the plug, the tip of plug driver broke.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; the device was inspected and the tips of both returned drivers were confirmed to be broken.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Trending report revealed, there are a relatively small proportion of total plug drivers that has fractured.Those that have fractured have occurred several years after release from manufacturing (implicating compounding wear and use).The most likely cause of the reported event was determined to be overloading from the user's cantilever force on the tip of the instrument with the age of 7+years.
Event or Problem Description
It was reported that during the surgery, the surgeon used plug driver in order to tighten plug of the connector.When the surgeon tightened the plug, the tip of plug driver broke.

• 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: 5661426
• Report Number: 0009617544-2016-00192
• Device Sequence Number: 16227521
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2016

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: 086192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 07/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1