MAUDE Adverse Event Report: STRYKER SPINE-US OVAL SHAVER SET 7-16MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	IS3048REL
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; 9mm shaver was placed in the disc space.When turned to remove disc material the shaver broke.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device was greater than 3 years old at the time of the event.Material analysis was concluded that the intact fracture areas exhibited a mixed mode of cleavage and ductile fractures.Conclusion: the most likely cause of the reported event was determined to be normal wear.
Event or Problem Description
It was reported that; 9mm shaver was placed in the disc space.When turned to remove disc material, the shaver broke.

• Brand Name: OVAL SHAVER SET 7-16MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 5804097
• Report Number: 3004024955-2016-00075
• Device Sequence Number: 1366854
• Product Code: LXH
• UDI-Device Identifier: 07613327142143
• UDI-Public: (01)07613327142143
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 06/22/2016

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: IS3048REL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2016
• Supplement Report FDA Received Date: 09/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1