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

Model Number	87011
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible.The instruments have not been returned for evaluation nor has the identifying lot number(s) 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
While inserting a screw into the iliac, the tips of both arsenal screwdrivers snapped and broke.The case was successfully completed.No patient harm.
Additional Manufacturer Narrative
An evaluation of the returned driver found that the distal tip of the instrument had fractured and became separated.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.

• Brand Name: LOCKING POLYAXIAL SCREWDRIVER (STAINLESS STEEL)
• Common Device Name: HXX
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8116159
• Report Number: 2027467-2018-00083
• Device Sequence Number: 1653160
• Product Code: HXX
• UDI-Device Identifier: 00844856069565
• UDI-Public: (01)00844856069565
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 87011
• Device Catalogue Number: 87011
• Device Lot Number: 7617501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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: 44 YR