MAUDE Adverse Event Report: ALPHATEC SPINE INC SCREW EXTENDER (STAINLESS STEEL); LXH

Model Number	73724
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records for both instruments found no manufacturing, processing or design related irregularities.Both instruments were found to be properly manufactured and released in accordance with the device master record.Although the device was properly manufactured additional investigation was conducted to determine root cause.The analysis showed that the failure mode observed in this event was due to imparting excessive torsional loads to the mating instrument (reducer) during the rod reduction maneuver.Excessive load can be applied due to a tolerance gap condition between the reducer and extenders.The over-torque observation was corroborated by the two design interface analyses (dias) that were performed on the reducer/screw extender interfaces.The second screw extender returned for evaluation is of the same product part number/description but contain a separate identifying lot number.Lot 7169901 manufactured 6/12/2014 - visual inspection found the extender shaft had fractured between the tab and the.225" rod channel, approximately.475" from the distal tip.The fracture begins at the rod channel and moves across distally towards the tip of the instrument where the extender attaches to the screw.It appears the screw extender may have been removed in a lateral direction while disengaging from the screw.
Event or Problem Description
An international customer (taiwan) reported the blades of two (2) illico screw extenders are damaged.The event caused over a 30 minute delay in the case.

• Brand Name: SCREW EXTENDER (STAINLESS STEEL)
• Common Device Name: LXH
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6529963
• Report Number: 2027467-2017-00022
• Device Sequence Number: 19042665
• Product Code: LXH
• UDI-Device Identifier: 00844856041691
• UDI-Public: 00844856041691
• 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
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 73724
• Device Catalogue Number: 73724
• 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