MAUDE Adverse Event Report: PRECISION SPINE, INC 4.5MM TAP; BONE TAP

Catalog Number PSST45

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

Patient Problem Failure of Implant (1924)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.Evaluation in process, not yet complete.

Event Description

During a procedure performed on (b)(6) 2017, after the pilot hole was made, the surgeon tried to redirect the path in a more appropriate direction using the 4.5mm tap.After tapping about half way the tap broke at the tip.The tip was removed and another tap of the same size was used to complete the procedure with a 5 minute delay.

Manufacturer Narrative

It was noted that the surgeon was attempting to redirect the path with the 4.5mm tap after initial pilot hole was made.Levering on the tap in an effort to try to redirect the tap is believed to be the likely cause for the observed failure.The cause for the complaint appears to be the result of misapplication of force and therefore no corrective actions are being proposed.Review of manufacturing history records found (b)(4) pieces of lot 28457 were released for distribution on 6/17/2011 with no deviation or anomalies.Complaint history review found this to be the first report of this nature for the reported lot since the date of manufacture.Further review of all taps in the psstxx family of taps did not reveal a trend for reports of this nature.The cause for the complaint appears to be the result of misapplication of force and therefore no corrective actions are being proposed.

• Brand Name: 4.5MM TAP
• Type of Device: BONE TAP
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: beth albert ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 6449676
• MDR Text Key: 71389436
• Report Number: 3005739886-2017-00023
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: PSST45
• Device Lot Number: 28457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention