MAUDE Adverse Event Report: ARTHREX, INC. RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
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
It was reported that during ankle arthroscopy procedure the curette broke.The broken off piece has been retrieved from the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8655-04 was received for investigation.Visual inspection identified that the distal tip of the ring curette had broken off, with no fragments received.The shaft diameter proximal to the breakage site was assessed using micrometer digital blade id: 224, and the device met design specifications.A probable cause can be attributed to prying/leveraging during use.

• Brand Name: RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 12570533
• Report Number: 1220246-2021-03728
• Device Sequence Number: 3586528
• Product Code: MDM
• UDI-Device Identifier: 00888867044272
• UDI-Public: 00888867044272
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: RING CURRETTE,ANKLE ARTHRSCPY,REVSE ANGL
• Device Catalogue Number: AR-8655-04
• Device Lot Number: 1392051
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown