MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RADIUS M A ADJUSTMENT TOOL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	486619100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; adjustment driver tip broke.Sales rep had another, no adverse consequences or surgical delay.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.The adjustment tool was used to remove a screw and install adjacent level with another manufacturer's screws in a revision surgery.There is no issue with the existing screw and the surgery was completed by using an alternative tool.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The likely cause of the reported event is normal wear and tear.Additional considerations are the force applied by the surgeon, and whether the screw that was being removed has fused and became unloose.
Event or Problem Description
It was reported that; adjustment driver tip broke.Sales rep had another, no adverse consequences or surgical delay.

• Brand Name: RADIUS M A ADJUSTMENT TOOL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7147341
• Report Number: 0009617544-2017-00439
• Device Sequence Number: 1497625
• Product Code: LXH
• UDI-Device Identifier: 07613327276053
• UDI-Public: (01)07613327276053
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/13/2018

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: No Information
• Device Model Number: 486619100
• Device Catalogue Number: 486619100
• Device Lot Number: 140989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR