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

Model Number	486619100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; height adjuster tip broke while adjusting screw.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, risk assessment; result: the reported event was confirmed fractured via visual inspection of the returned product.All fragments were removed and there was no reported delay.Manufacturing files were reviewed and no issues were found.The stryker rep confirmed that the instrument was being used correctly during surgery.The likely root causes of the deformation was instrument age, normal wear and tear.
Event or Problem Description
It was reported that; height adjuster tip broke while adjusting screw.There are no reports of adverse consequences to the patient.

• Brand Name: RADIUS M A ADJUSTMENT TOOL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7160565
• Report Number: 0009617544-2018-00001
• Device Sequence Number: 1994275
• Product Code: LXH
• UDI-Device Identifier: 07613327276053
• UDI-Public: (01)07613327276053
• Combination Product (Y/N): N
• 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): 05/24/2018

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: 04/11/2018
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1