MAUDE Adverse Event Report: ALPHATEC SPINE, INC. TAP, CANNULATED, 4.5 MM (STAINLESS STEEL); HWX

Model Number	73715
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The instrument has not been returned for evaluation.Upon the receipt of additional information and/or the return of the illico tap a follow-up report will be submitted.
Event or Problem Description
An international customer ((b)(6)) reported the patient had extremely hard bone.The tip of the tap was broken at s1 while the surgeon was creating a hole into the pedicle through the dilator.Removal of the detached tip was unsuccessful.It remains entrapped within the patient's s1.
Additional Manufacturer Narrative
Evaluation of the returned cannulated tap found that the distal tip had fractured and became separated from the instrument.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.The detached tip which remains positioned within the patients s1 was manufactured from 465ss (stainless steel) and is certified to astm a564 specifications.It appears that this occurrence is likely the result of implantation in hard dense bone, which required an increased torsional load that exceeded the design limits of the instrument.

• Brand Name: TAP, CANNULATED, 4.5 MM (STAINLESS STEEL)
• Common Device Name: HWX
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 7885781
• Report Number: 2027467-2018-00067
• Device Sequence Number: 2365241
• Product Code: HWX
• UDI-Device Identifier: 00844856044005
• UDI-Public: (01)00844856044005(10)6918102
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 73715
• Device Catalogue Number: 73715
• Device Lot Number: 6918102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/16/2018
• 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: 71 YR