MAUDE Adverse Event Report: ARTHREX, INC. BURR ATTACHMENT 2.35 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number BURR ATTACHMENT 2.35 MM

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Date 10/31/2023

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 11/7/2023, it was reported by a sales representative via (b)(4) that an ar-300b burr attachment does not firmly hold burrs and will fall out with no impact on the case reported.It was stated that it held the burr through the procedure enough to complete it with no impact on patient.This was discovered during a calcaneal slide procedure on (b)(6) 2023, with no reported patient harm.

Manufacturer Narrative

Additional information: h6.The complaint is confirmed.One unpackaged ar-300b serial/batch number 07101 was received for investigation.Functional testing connecting the burr attachment to the ar-300, sn (b)(6) found no issues attaching the burr and locking into the mating part.Visual evaluation inside the device with a nano camera found that the open/close mechanism is not moving when activated.The most likely cause(s) for the reported failure is user error per dfu-0223 at revision 0.Important safety conventions.6.Prior to each use, fully assemble the system and press the trigger mechanism to ensure proper function.All couplings and mechanical connections need to be fully secured or locked before the actuation of the system.

• Brand Name: BURR ATTACHMENT 2.35 MM
• Type of Device: POWERED SURG ORTHOPEDIC 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: emily shafer ; 8009337001
• MDR Report Key: 18257932
• MDR Text Key: 329621443
• Report Number: 1220246-2023-09130
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867099968
• UDI-Public: 00888867099968
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BURR ATTACHMENT 2.35 MM
• Device Catalogue Number: AR-300B
• Device Lot Number: 14456092
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1