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

Model Number	87011
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records revealed no irregularities.The instrument was found to be properly manufactured and released in accordance with the device master record.Visual inspection found a section of the threads nearest the relief area have fractured and become detached from the instrument.The male threads of the polyaxial screwdriver mate with the female threads of the polyaxial screw in order to advance/anchor the screw into the desired location.The collar component in which the threads are located is manufactured from (b)(4) and comply to atsm a564 standards.A previous investigation conducted for this type of occurrence determined that when the instrument is not completely disengaged/unthreaded from the mating screw, upon removal excessive force is placed on the male threads causing them to fracture and break.
Event or Problem Description
The threads on the right side of the polyaxial screwdriver broke off while inserting a mating polyaxial screw.The surgeon retrieved the broken pieces from patient but not all of the fragments were removed.

• 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: 6018376
• Report Number: 2027467-2016-00079
• Device Sequence Number: 16230130
• Product Code: HXX
• UDI-Device Identifier: 00844856069565
• UDI-Public: 00844856069565
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2016

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: Physician
• Device Model Number: 87011
• Device Catalogue Number: 87011
• Device Lot Number: 7510401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Initial Report FDA Received Date: 10/11/2016
• 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: 66 YR