MAUDE Adverse Event Report: ARTHREX, INC. T10 HEXALOBE, CMP FT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number T10 HEXALOBE, CMP FT

Device Problem Break (1069)

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

Event Date 10/11/2022

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 10/13/2022, it was reported by a sales representative via sems that an ar-8737-38 driver shaft, t10 hex, cannulated had an issue, the tip broke off, star t driver shattered at the tip.Discovered during case, rep will follow up with x-ray, fragments were retrieved and were not left in the patient.This was discovered during use in an unspecified procedure on (b)(6) 2022 with no impact to the patient.Additional information has been requested.On 10/20/2022, the sales representative who attended the case, provided the following information via mail: this event occurred during an orif metacarpal procedure.She arrived late in the case that day and was not able to confirm if x-rays were taken to verify if any fragments were left inside the patient.No drill guide was used and the instrument was not used with power.The procedure was completed successfully, and the patient is fine to date.

Manufacturer Narrative

Complaint confirmed.Upon visual inspection it was noted that the drive geometry at the distal tip of the returned ar-8737-38 had broken off.No fragments were returned for inspection.A probable cause is attributed to over-torquing/over-engaging the driver within the screw head.The cause remains undetermined.

• Brand Name: T10 HEXALOBE, CMP FT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15698325
• MDR Text Key: 307073869
• Report Number: 1220246-2022-05677
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867127166
• UDI-Public: 00888867127166
• 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,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T10 HEXALOBE, CMP FT
• Device Catalogue Number: AR-8737-38
• Device Lot Number: 1392107
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1