MAUDE Adverse Event Report: ALPHATEC SPINE INC 6.5MM TAP (STAINLESS STEEL); HWX

Model Number 87007-065

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2016

Event Type  malfunction  

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 it fractured and separated at the 60mm depth grove indicator.A previous investigation for this type of event found that it results from multiple contributing factors including surgical technique, misuse, patient bone quality, improper measurement technique of the tap flutes.

Event Description

While using the 6.5 tap it broke off in the patient but was able to retrieve.

• Brand Name: 6.5MM TAP (STAINLESS STEEL)
• Type of Device: HWX
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard welch ; 5818 el camino real; carlsbad, CA 92008 ; 7604946611
• MDR Report Key: 6154569
• MDR Text Key: 62335348
• Report Number: 2027467-2016-00108
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 87007-065
• Device Catalogue Number: 87007-065
• Device Lot Number: 740903S1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR