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

Model Number	IS3048REL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the surgeon was prepping the disc space to place an inter-body cage, the 7mm and 8mm custom oval shavers broke in the patient.A backup shaver was used to complete the procedure.Fragments were retrieved successfully.There are no reports of adverse consequences to the patient.
Event or Problem Description
It was reported that while the surgeon was prepping the disc space to place an inter-body cage, the 7mm and 8mm custom oval shavers broke in the patient.A backup shaver was used to complete the procedure.Fragments were retrieved successfully.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event was confirmed via visual inspection.The device was returned in 2 pieces, with the tip of the device fractured off.The fractured tip was twisted and deformed.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.A material analysis was performed.Shaver was found to have a fracture origin in the raised end and a mixed mode fracture of mostly cleavage with some ductile due to an applied torsional force.The hardness and chemical constituents were as specified on the drawing.No material or manufacturing defects were found.Correspondence with sales representative indicated that the products have been used in 100+ cases and the patient's bone quality was solid.From instruments ifu, the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.The most likely cause of the reported event was determined to be normal wear due to excessive use.

• 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: 7479032
• Report Number: 3004024955-2018-00025
• Device Sequence Number: 13851126
• 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): 09/25/2018

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: IS3048REL
• Device Catalogue Number: IS3048REL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1