MAUDE Adverse Event Report: ALPHATEC SPINE INC MIS REDUCTION POLYAXIAL SCREWDRIVER, LOCKING (STAINLESS STEEL, RADEL); HXX

Model Number	16015-04
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned instrument is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
The tip snapped off the screwdriver while driving in the screw.The detached section remains entrapped beneath the rod and set screw.
Additional Manufacturer Narrative
Visual inspection of the returned polyaxial screwdriver found that the distal tip had fractured and became separated from the instrument.The evaluation determined the failure was the results of a torsional overload.

• Brand Name: MIS REDUCTION POLYAXIAL SCREWDRIVER, LOCKING (STAINLESS STEEL, RADEL)
• Common Device Name: HXX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8544766
• Report Number: 2027467-2019-00019
• Device Sequence Number: 16758797
• Product Code: HXX
• UDI-Device Identifier: 00190376146621
• UDI-Public: (01)00190376146621(10)8205603R1
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 16015-04
• Device Catalogue Number: 16015-04
• Device Lot Number: 8205603R1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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