MAUDE Adverse Event Report: PRECISION SPINE, INC. CUSTOM INSTRUMENT; TAP

Catalog Number C2873-45

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure performed on (b)(6) 2020, the tip of the 4.5mm reform tap, blb adapter (c2873-45) broke.The broken tip was retrieved from the patient easily using a caliper and the procedure was completed using the 5.5mm tap that was readily accessable.There was no patient issue or delay to the procedure reported.

Manufacturer Narrative

D10 device available for evaluation - information received on january 11, 2021 indicates that the device will not be returned as it was discarded at the hospital.H3 device evaluation - without the ability to examine the complaint product, no conclusions can be drawn as to the root cause of the failure.As root cause could not be determined and there was not a trend for issues of this nature for the reported part number, the need for corrective action is not indicated.Review of device history records found two (2) pieces of lot ap18588-1 were released for distribution on 4/25/2018 with no deviation or anomalies.Two-year complaint history review (11/26/2018-11/26/2020) found this to be the only report of this nature for this part number.

Event Description

During a procdure performed on (b)(6) 2020, the tip of the 4.5mm reform tap, blb adapter (c2873-45) broke.The broken tip was retrieved from the patient easily using a caliper and the procedure was completed using the 5.5mm tap that was readily accessable.There was no patient issue or delay to the procedure reported.

• Brand Name: CUSTOM INSTRUMENT
• Type of Device: TAP
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 11029115
• MDR Text Key: 222096016
• Report Number: 3005739886-2020-00051
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C2873-45
• Device Lot Number: AP18588-1
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR