MAUDE Adverse Event Report: ARTHREX, INC. C-MOUNT HIP AR-SCOPE 70,3.5X 204MM; ARTHROSCOPE

Model Number	C-MOUNT HIP AR-SCOPE 70°,3.5X 204MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2021
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 a hip arthroscopic / labral reconstruction procedure, the distal tip of the scope broke off into the patient.No additional information provided.Additional information requested.Additional information: halfway through the case the surgeon discovered a piece of the scope on the x-ray machine inside the soft tissue.The surgeon made short attempt to retrieve it but was unsuccessful and continued with the procedure.At the very end of the case they spent 45 minutes to locate it inside the patient and additional x-rays were taken but they were unable to retrieve the fragment.The doctor used a non-arthrex shaver and burr which came in contact with the scope which severed part of the scope.
Additional Manufacturer Narrative
Complaint was confirmed.Visual evaluation confirmed the condition of the distal tip fibers and welded metal tubing are broken.Broken piece was not returned.It was also observed, scratches around shaft at the distal end and around the lens of the device.Based on the device evaluation, the cause of the event is misuse by the end user, as stated in the complainant's narrative that the burr came in contact with the scope which severed part of the scope.

• Brand Name: C-MOUNT HIP AR-SCOPE 70,3.5X 204MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12196505
• Report Number: 1220246-2021-03403
• Device Sequence Number: 5244759
• Product Code: HRX
• UDI-Device Identifier: 00888867029873
• UDI-Public: 00888867029873
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 10/14/2021

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 HIP AR-SCOPE 70°,3.5X 204MM
• Device Catalogue Number: AR-3355-4070H
• Device Lot Number: 11673164
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1