MAUDE Adverse Event Report: ARTHREX INC. T25 HEXALOBE, ISO, CANN.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number AR-8770-01

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

Patient Problem Tissue Damage (2104)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the distal tip was broken off.Broken drive is typically caused when excessive force is being applied on the device during use and/or over-torquing when the screw is already seated.The device met all material specifications as received.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that during an ankle fusion procedure, as the surgeon was inserting a 7.0 headless ft screw across the ankle joint, the tip of the t25 hexalobe driver broke off but remained in the head of the screw.The surgeon made 2nd incision to retrieve the tip of the driver.The driver tip was retrieved and the case proceeded as planned.Patient is a male, (b)(6).Follow-up investigation: the tip of the driver was thrown away.The initial incision was made to place a percutaneous guide wire for the screw.The second incision was made as close to the inserted screw as possible in an attempt to retrieve the tip of the broken metal driver from the recessed "head" of the screw.

• Brand Name: T25 HEXALOBE, ISO, CANN.
• 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7577711
• MDR Text Key: 110358847
• Report Number: 1220246-2018-00202
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867263789
• UDI-Public: 00888867263789
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-8770-01
• Device Lot Number: 031742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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: 37 YR