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

Model Number	87011
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the pelvic screw is not possible.The explanted device has been discarded by the user facility.Neither the identifying part and/or lot number have been provided.The second screwdriver reported is of the same product part number but contains a separate manufacturing lot number : 7405101r1 manufactured 3/2/2015.Evaluation of the returned drivers found that the distal tips of both instruments had fractured and became separated.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.The detached tips were both recovered from the patient and discarded by the user facility.
Event or Problem Description
Pelvic screw broke near head about 90mm in.Two screwdrivers were broken during insertion and removal.Ez out eventually removed the broken screw.Event caused an hour delay in the case.

• 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: 7845838
• Report Number: 2027467-2018-00064
• Device Sequence Number: 13765353
• Product Code: HXX
• UDI-Device Identifier: 00844856069565
• UDI-Public: (01)00844856069565(10)MC4163503
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 08/09/2018

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: Health Professional
• Device Model Number: 87011
• Device Catalogue Number: 87011
• Device Lot Number: MC4163503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/05/2018
• 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: Hospitalization