MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR C 10MM DRILL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Model Number	48328910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was attempting to implant a spacer into the disc space.He began to drill the first screw hole with the 10 mm rigid drill; and snapped it in half in the drill guide.He began trying to retrieve it and had to take apart the cage to do so.The cage was then wasted.He put in a new cage and "awled" this time which seemed to have worked.
Event or Problem Description
It was reported that the surgeon was attempting to implant a spacer into the disc space.He began to drill the first screw hole with the 10mm rigid drill; and snapped it in half in the drill guide.He began trying to retrieve it and had to take apart the cage to do so.The cage was then wasted.He put in a new cage and awled this time which seemed to have worked.

• Brand Name: ANCHOR C 10MM DRILL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6878469
• Report Number: 0009617544-2017-00361
• Device Sequence Number: 706516
• Product Code: LXH
• UDI-Device Identifier: 07613327267631
• UDI-Public: (01)07613327267631
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/30/2017

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 Model Number: 48328910
• Device Catalogue Number: 48328910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1