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	11/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records found no manufacturing, processing or design related irregularities.The instrument was found to be properly manufactured and released in accordance with the device master record.Inspection of the returned screw extender revealed two small sections had fractured and broke on both sides of the extender shaft.The irregularity begins at the distal tip and migrates up along the.225" rod channel then breaks out at approximately.365 of an inch.When used in accordance with the illico surgical technique guide, users should not expect to encounter this type of event.Illico surgical technique guide lit-83323 provides direction as to proper detachment of the screw extender from the mating polyaxial screw."insert screw remover into screw extender with handle parallel to the implant rod.Rotate 90 degrees clockwise.Gently pull t-handle up to release screw extender.If the screw extender does not disengage, do not use force.Use screw remover aid.".
Event or Problem Description
An international customer ((b)(6)) reported the blade of an illico screw extender is 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: 6530165
• Report Number: 2027467-2017-00035
• Device Sequence Number: 808600
• 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
• Device Lot Number: 7169801
• 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