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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. LOW-PROFILE AC REPAIR SYSTEM; WASHER, BOLT NUT
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ARTHREX, INC. LOW-PROFILE AC REPAIR SYSTEM; WASHER, BOLT NUT Back to Search Results
Model Number LOW-PROFILE AC REPAIR SYSTEM
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 11/13/2020
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 the surgeon has identified that 4 to 5 weeks after the initial surgery the low profile screw got broken.There was no harm for patient, operator or third party reported.This was noticed after the surgery.No further information received.Update 8-dec-2020 dw.Further information were provided that the initial surgery was performed on (b)(6) 2020 and a revision was performed on (b)(6) 2020.
 
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Brand Name
LOW-PROFILE AC REPAIR SYSTEM
Common Device Name
WASHER, BOLT NUT
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11075962
Report Number1220246-2020-02437
Device Sequence Number14254658
Product Code HTN
UDI-Device Identifier00888867256637
UDI-Public00888867256637
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K052776
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/28/2020
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 NumberLOW-PROFILE AC REPAIR SYSTEM
Device Catalogue NumberAR-2371
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/08/2020
Initial Report FDA Received Date12/28/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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