MAUDE Adverse Event Report: ALPHATEC SPINE INC 5.5 MM TAP (STAINLESS STEEL); HWX

Model Number	87107-055
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The instrument has not been returned for evaluation nor has the identifying lot number 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 tapping the pedicle, the 5.5mm tap broke.The surgeon removed the threaded tip from the patients bone and the surgery completed without further issue.The event caused no patient harm.
Additional Manufacturer Narrative
An evaluation of the suspect device revealed no manufacturing or processing related irregularities.The instrument was found to be properly manufactured and released in accordance with design specifications.Visual inspection of the returned arsenal tap revealed the instrument fractured and separated at the 60mm depth indicator.The fractured ends appear to be crisp and clean and suggest the break occurred in snapping motion rather than a rotation direction that would be expected with the instruments intended use.Under magnification, the edges of both corresponding halves display an angulated fracture pattern indicative of excessive lateral bending.

• Brand Name: 5.5 MM TAP (STAINLESS STEEL)
• Common Device Name: HWX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8649801
• Report Number: 2027467-2019-00027
• Device Sequence Number: 2663265
• Product Code: HWX
• UDI-Device Identifier: 00840967126838
• UDI-Public: (01)00840967126838
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/30/2019

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: 87107-055
• Device Catalogue Number: 87107-055
• Device Lot Number: 7673704S1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/21/2019
• 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: 68 YR