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	04/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor was prepping the disc space with the 7mm oval shaver, shaver broke in the disc.Fragment was retrieved without adverse consequences.The next size up shaver was used.
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 5 years old at the time of the event.Conclusion: based on the visual inspection and the device age, the most likely cause of the reported event was determined to be normal wear.
Event or Problem Description
It was reported that the doctor was prepping the disc space with the 7mm oval shaver, shaver broke in the disc.Fragment was retrieved without adverse consequences.The next size up shaver was used.

• 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: 6565077
• Report Number: 3004024955-2017-00020
• Device Sequence Number: 18972168
• Product Code: LXH
• UDI-Device Identifier: 07613327142143
• UDI-Public: (01)07613327142143
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/28/2017

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: 06/14/2017
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1