MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR L DRILL 5MM MODULAR RIGID; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48999150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the tip of the rigid drill bit broke off during surgery when he was using it to make a screw hole in the vetebral body.
Additional Manufacturer Narrative
Method: risk assessment.Results: visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the definitive root cause of the event cannot be determined from the given information.
Event or Problem Description
It was reported that; the tip of the rigid drill bit broke off during surgery when he was using it to make a screw hole in the vertebral body.

• Brand Name: ANCHOR L DRILL 5MM MODULAR RIGID
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6989414
• Report Number: 0009617544-2017-00388
• Device Sequence Number: 13575198
• Product Code: LXH
• UDI-Device Identifier: 07613327275087
• UDI-Public: (01)07613327275087
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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: 48999150
• Device Catalogue Number: 48999150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 73