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U.S. Department of Health and Human Services

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

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ARTHREX, INC. C-MOUNT HIP AR-SCOPE 70,3.5X 204MM ARTHROSCOPE Back to Search Results
Model Number C-MOUNT HIP AR-SCOPE 70°,3.5X 204MM
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/30/2021
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
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.
 
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Brand NameC-MOUNT HIP AR-SCOPE 70,3.5X 204MM
Type of DeviceARTHROSCOPE
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 Key12196505
MDR Text Key264715121
Report Number1220246-2021-03403
Device Sequence Number1
Product Code HRX
UDI-Device Identifier00888867029873
UDI-Public00888867029873
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC-MOUNT HIP AR-SCOPE 70°,3.5X 204MM
Device Catalogue NumberAR-3355-4070H
Device Lot Number11673164
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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