MAUDE Adverse Event Report: ARTHREX, INC. C-MOUNT AR-SCOPE,302.7X 72MM LGTH; ARTHROSCOPE

Model Number	C-MOUNT AR-SCOPE,30°2.7X 72MM LGTH
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
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 the ar-3355-2730 scope is damaged.Additional information on 7/21/2021: it was reported by the sales rep, that during an ankle procedure on (b)(6) 2021 with dr.Hull.The surgeon was using ar-3355-2730 c-mount 2.7 scope, after insertion, the shaft broke when the surgeon was trying to look deep inside the ankle joint, under the talus.The broken piece was removed.The case was completed using a back up ar-3355-2730 c-mount 2.7 scope.

• Brand Name: C-MOUNT AR-SCOPE,302.7X 72MM LGTH
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12300620
• Report Number: 1220246-2021-03500
• Device Sequence Number: 19929040
• Product Code: HRX
• UDI-Device Identifier: 00888867029835
• UDI-Public: 00888867029835
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• 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
• Report Date (Section B): 08/10/2021

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: C-MOUNT AR-SCOPE,30°2.7X 72MM LGTH
• Device Catalogue Number: AR-3355-2730
• Device Lot Number: 10239869
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/10/2021
• Patient Sequence Number: 1