MAUDE Adverse Event Report: ARTHREX, INC. 30MM TAP; ORTHOPEDIC MANUAL SURG INSTR

Model Number 30MM TAP

Device Problem Break (1069)

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

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 4/5/2024, a sales representative via (b)(4) reported that an ar-9621-30t 30mm tap on the tip of the tap broke off into the patient during mgs central tapping.The surgeon was able to retrieve all the pieces from the patient.The case was completed using a 35 tap and screw, and no secondary surgery is needed.This was discovered during an rsa procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 4/10/2024: there was no delay in the case reported.They removed the fragments and tapped to a 35, and used a 24+4/35 screw to complete the case.

• Brand Name: 30MM TAP
• Type of Device: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19216200
• MDR Text Key: 341499080
• Report Number: 1220246-2024-02646
• Device Sequence Number: 1
• Product Code: LXH
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30MM TAP
• Device Catalogue Number: AR-9621-30T
• Device Lot Number: 022143
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/05/2024
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2021
• 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