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

Model Number	62979
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The instrument has not been returned for evaluation nor has the identifying lot number been provided.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
The tip broke off in the patient during surgery.
Additional Manufacturer Narrative
Review of the device history records revealed the instrument was properly manufactured and released in accordance with design specifications.No irregularities have been identified.Visual inspection revealed that approximately 0.100" of the distal tip had fractured and separated from the device.Root cause appears to be improper use of the instrument.The bridge driver (62979) is design to be used in conjunction with the 40 in-lbs torque handle 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.Tr-433a; 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.It is unknown if the detached section remains entrapped within the set screw of the implanted adjustable bridge.Multiple attempts to obtain information have gone unanswered.The adjustable bridge driver, lot# 6274101 was manufactured from (b)(4) (stainless steel) and is certified to astm a564-10.

• 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: 6094548
• Report Number: 2027467-2016-00088
• Device Sequence Number: 841183
• Product Code: HXX
• UDI-Device Identifier: 00844856026810
• UDI-Public: 00844856026810
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Supplement Report FDA Received Date: 11/28/2016
• 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
• Patient Age: 56 YR