MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL PILOT CUTTER; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48921002
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had hard bone and the cutters in the set were not sharp enough.The surgeon was unable to cut the pilot holes.Surgeon used another stryker brand product to complete the surgery.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment results: the customer reported event was confirmed via visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the reported event was determined to be a combination of the following factors: the usage age (2 years) and the usage frequency (many times) of the returned devices; the surgery was done on l5/s1, where the bone is relatively harder than other body parts; overload of the cantilever force applied during the channel creation or cutter removal.
Event or Problem Description
It was reported that the patient had hard bone and the cutters in the set were not sharp enough.The surgeon was unable to cut the pilot holes.Surgeon used another stryker brand product to complete the surgery.

• Brand Name: AERO AL PILOT CUTTER
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5692854
• Report Number: 0009617544-2016-00214
• Device Sequence Number: 10897511
• Product Code: OVD
• UDI-Device Identifier: 07613252662952
• UDI-Public: (01)07613252662952
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/09/2016

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: 48921002
• Device Lot Number: 144678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2016
• Supplement Report FDA Received Date: 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1