MAUDE Adverse Event Report: ALPHATEC SPINE INC ADJUSTABLE BRIDGE DRIVER (STAINLESS STEEL); HXX

Model Number	62979
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the returned bridge driver (62979) found the detached section which remains entrapped within the set screw of the implanted adjustable bridge is approximately.203" in length.The instrument was manufactured from 465ss (stainless steel) and is certified to astm (b)(4).Additional information provided by the sales rep revealed the scrub tech inadvertently attached the 100 in-lb torque wrench (62957) to the adjustable driver (62979) assembly.The bridge driver (62979) is design to be used in conjunction with the 40 in-lbs torque wrench (62943) which delivers the proper amount of torque to the set screws within the zodiac adjustable bridge.Once 40 in-lbs of torque is achieved an audible click will be heard indicating the screws are properly seated and no additional torque can delivered.(b)(4); adjustable bridge driver verification testing found that an average of 90 in-lbs of torque was required to reproduce this type of failure.The test established when the instrument is used as intended the tip of the bridge driver will not deform and/or fracture.
Event or Problem Description
The tip of the zodiac driver broke off during final tightening.The detached section remains positioned within the set screw of the implanted adjustable bridge.

• Brand Name: ADJUSTABLE BRIDGE DRIVER (STAINLESS STEEL)
• Common Device Name: HXX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5883596
• Report Number: 2027467-2016-00062
• Device Sequence Number: 1164058
• Product Code: HXX
• UDI-Device Identifier: 00844856026810
• UDI-Public: 00844856026810
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2016

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?: No
• Operator of Device: Physician
• Device Model Number: 62979
• Device Catalogue Number: 62979
• Device Lot Number: 6856601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2016
• Initial Report FDA Received Date: 08/17/2016
• 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