MAUDE Adverse Event Report: ARTHREX, INC. BURR, STRAIGHT 20 MM, DIA. 3.1 MM; BURR,SURGICAL

Model Number	BURR, STRAIGHT 20 MM, DIA. 3.1 MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On 12/6/2023, it was reported by a sales representative that an ar-300b burr attachment and an ar-300-b202 burr had an issue.During a routine minimally invasive surgery (mis) calcaneal slide, ar-300-b202 broke off at the shaft during joint prep.The surgeon was able to remove the burr head from the bone, but the inserter portion of the burr is in ar-300b (head portion of mis handpiece) and unable to be removed by multiple people.The case was completed by opening a new handpiece and burr to complete the procedure with no pieces left in the patient.There was a 5 minute delay due to removing the burr and opening a new handpiece/burr.It was stated that the surgeon does around 8 mis calc slides monthly and is very comfortable with the procedure.This was discovered during a calc osteotomy procedure on (b)(6) 2023, with no reported adverse effects to the patient.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-300-b202 was received for investigation.The evaluated device was the ar-300b serial/batch number (b)(6).Functional testing was not performed because the device was damaged.Visual evaluation of the ar-300b noted that the device has an obstruction inside the hole where the burr is plugged, presumably the reported broken burr.The most likely cause of the observed failure is a use error.When two devices are intended to be threaded/mated together, ensure they are fully engaged before use.

• Brand Name: BURR, STRAIGHT 20 MM, DIA. 3.1 MM
• Common Device Name: BURR,SURGICAL
• 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: 18438413
• Report Number: 1220246-2024-00063
• Device Sequence Number: 12500192
• Product Code: LXH
• UDI-Device Identifier: 00888867185821
• UDI-Public: 00888867185821
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BURR, STRAIGHT 20 MM, DIA. 3.1 MM
• Device Catalogue Number: AR-300-B202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown