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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,CMC MINI T-ROPE,1.1 MM; WASHER, BOLT NUT
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ARTHREX, INC. IMPL SYS,CMC MINI T-ROPE,1.1 MM; WASHER, BOLT NUT Back to Search Results
Model Number IMPL SYS,CMC MINI T-ROPE,1.1 MM
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/25/2020
Type of Reportable Event Serious Injury
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.
 
Event or Problem Description
It was reported that a patient's underwent a procedure where a cmc tightrope, ar-8919ds, was implanted in their hand.About 4-6 months post-op, the patient began to experience distortion of the anatomy and the surgeon plans to revise surgery.No further information provided.Additional information obtained 9/8/20: arthrex has been advised that the patient underwent a revision procedure (b)(6) 2020 during which time the ar-8919ds was explanted.
 
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Brand Name
IMPL SYS,CMC MINI T-ROPE,1.1 MM
Common Device Name
WASHER, BOLT NUT
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key10562315
Report Number1220246-2020-02185
Device Sequence Number19538785
Product Code HTN
UDI-Device Identifier00888867048966
UDI-Public00888867048966
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K090107
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberIMPL SYS,CMC MINI T-ROPE,1.1 MM
Device Catalogue NumberAR-8919DS
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/08/2020
Initial Report FDA Received Date09/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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