MAUDE Adverse Event Report: ALPHATEC SPINE INC 2.1MM FIXED DEPTH DRILL 12MM (STAINLESS STEEL. TI-6AL-4V ELI); LXH

Model Number	63928-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into the returned instrument found that the drill stop measured approximately 5mm more proximal than print requirements/tolerance.This allowed the drill to be inserted through the drill guide and the tip to extend an additional 5mm further than intended.Additional testing found documentation that the force required to drill into human femur bone is 198.4+/-14.2n.Because human femur bone is denser than vertebral pedicle or lateral mass bone, this value indicates a worst case drilling condition.The returned drill tested exceeds the worst case scenario and would most likely not slide/move during use.
Event or Problem Description
During the surgery, when the 12mm fixed drill was inserted into the drill guide it was noticed that 15mm was protruding.The surgeon used a different 12mm fixed drill and completed the surgery without issue.The event caused no patient harm.

• Brand Name: 2.1MM FIXED DEPTH DRILL 12MM (STAINLESS STEEL. TI-6AL-4V ELI)
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5614653
• Report Number: 2027467-2016-00031
• Device Sequence Number: 18837507
• Product Code: LXH
• UDI-Device Identifier: 00844856007758
• UDI-Public: 00844856007758
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2015

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: Physician
• Device Model Number: 63928-12
• Device Catalogue Number: 63928-12
• Device Lot Number: 6696103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2016
• Initial Report FDA Received Date: 04/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other