MAUDE Adverse Event Report: ALPHATEC SPINE INC TORQUE WRENCH SHAFT (STAINLESS STEEL); HXC

Model Number	73753
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records revealed no manufacturing, processing or design related irregularities.The instrument was found to be properly manufactured and released in accordance with the device master record.Visual inspection of the returned instrument found approximately half of the.2146" male hexalobe feature is damaged in that it was detached/removed for the distal tip of the driver.When used as intended the instrument would not come in contact with the amount of force required to deform and/or break the tip in this manner.Multiple attempts to obtain additional information have gone unanswered.Upon the receipt of additional information a follow report will be submitted.
Event or Problem Description
An international customer (b)(6) reported the tip of the illico torque shaft had broken.The event caused over a 30 minute delay in the case.

• Brand Name: TORQUE WRENCH SHAFT (STAINLESS STEEL)
• Common Device Name: HXC
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6530053
• Report Number: 2027467-2017-00034
• Device Sequence Number: 788626
• Product Code: HXC
• UDI-Device Identifier: 00844856036062
• UDI-Public: 00844856036062
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Model Number: 73753
• Device Catalogue Number: 73753
• Device Lot Number: 6925401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 04/28/2017
• 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