MAUDE Adverse Event Report: ALPHATEC SPINE INC DRILL (STAINLESS STEEL); HTW

Model Number	51907
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that two aspida drills were utilized during the case, one of which broke.Both instruments are of the same product part number/description but contain a separate identifying lot numbers.It is unknown which manufacturing lot number belongs to the fractured instrument.Lot: 7325601, manufactured 8/21/2014; lot: 6232206, manufactured: 3/7/2011.A review of the device history records for both instruments revealed no manufacturing or processing related irregularities.The instruments were found to be properly manufactured and released in accordance with design specifications.No evaluation possible at this time.Multiple attempts to obtain the instrument have been unsuccessful.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
An aspida drill bit broke off in the patient while creating a pilot hole.The detached section remains positioned within the anterior wall of the l5 vertebral body.
Additional Manufacturer Narrative
An evaluation both returned instrument found that manufacturing lot# 7325601 represents the fractured instrument.The detached section which remains within the patients anterior wall of the l5 vertebral body, is approximately.870" in length and manufactured from 465ss which complies with astm standards.Additional inspection under magnification found that the instrument appears to have failed due to excessive lateral bending and not a twisting motion that would be expected with the use of this device.

• Brand Name: DRILL (STAINLESS STEEL)
• Common Device Name: HTW
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8544876
• Report Number: 2027467-2019-00020
• Device Sequence Number: 18922552
• Product Code: HTW
• UDI-Device Identifier: 00844856037113
• UDI-Public: (01)00844856037113
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 51907
• Device Catalogue Number: 51907
• Device Lot Number: 7325601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/10/2019
• 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
• Patient Age: 71 YR