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

Model Number	48994150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the surgeon, reported that as he was using the drill bit, a piece snapped off and became embedded in the patient's bone (specifically the anterior vertebral body l5s1).The surgeon used rongeurs to remove the piece and this added 15 minutes ot the surgery.Normally the surgeon would use an awl to make a 'hole' prior to drilling.In this case the awl was not used.The stryker sales representative, was in the case.
Additional Manufacturer Narrative
The fracture of a drill tip was confirmed via visual inspection.Per analysis, the tip fractured due to unidirectional bending.No material and manufacturing defects were found.The plausible root cause is applying too much cantilever force to the drill.
Event or Problem Description
It was reported that; the surgeon, reported that as he was using the drill bit, a piece snapped off and became embedded in the patient's bone (specifically the anterior vertebral body l5s1).The surgeon used rongeurs to remove the piece and this added 15 minutes ot the surgery.Normally the surgeon would use an awl to make a 'hole' prior to drilling.In this case the awl was not used.The stryker sales representative, was in the case.

• Brand Name: ANCHOR L DRILL 5MM MODULAR FLEXIBLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6667985
• Report Number: 0009617544-2017-00259
• Device Sequence Number: 16347743
• Product Code: LXH
• UDI-Device Identifier: 07613327274592
• UDI-Public: (01)07613327274592
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 09/20/2017

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: 48994150
• Device Catalogue Number: 48994150
• Device Lot Number: 14F926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1