MAUDE Adverse Event Report: ALPHATEC SPINE, INC. AWL (STAINLESS STEEL); HWJ

Model Number	73711
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The instrument has not been returned for evaluation.The illico awl is a cannulated instrument ground at 15° to form a sharp trocar tip intended to penetrate cortical bone during pedicle preparation.The section retained by the patient is manufactured from custom (b)(4) stainless steel which is processed and certified to astm (b)(4) specifications.
Event or Problem Description
The distal tip of an illico awl broke off during the mis case.The detached section remains captured within the patients l5 pedicle.
Additional Manufacturer Narrative
An evaluation of the returned device confirmed the distal tip, approximately.591 in length has been completely separated/detached from the instrument.Under magnification, the fracture patterns reveal lateral forces where applied to the instrument which caused the ø.20" tip to encounter excessive fatigue/stress.

• Brand Name: AWL (STAINLESS STEEL)
• Common Device Name: HWJ
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 7482962
• Report Number: 2027467-2018-00023
• Device Sequence Number: 13480872
• Product Code: HWJ
• UDI-Device Identifier: 00844856043961
• UDI-Public: (01)00844856043961
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: Physician
• Device Model Number: 73711
• Device Catalogue Number: 73711
• Device Lot Number: 5148702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/11/2018
• 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: 52 YR