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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, CORKSCREW FT II; SCREW, FIXATION, BONE
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ARTHREX, INC. SUTURE ANCHOR, CORKSCREW FT II; SCREW, FIXATION, BONE Back to Search Results
Model Number SUTURE ANCHOR, CORKSCREW FT II
Device Problems Use of Device Problem (1670); Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 03/22/2021
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.
 
Event Description
It was reported that during a rotator cuff procedure, the ar-1928sf-2 was cut and could no longer be used.The fragment was removed and the case was completed by using a new ar-1928sf-2.
 
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Brand Name
SUTURE ANCHOR, CORKSCREW FT II
Type of Device
SCREW, FIXATION, BONE
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 Key11688572
MDR Text Key248535655
Report Number1220246-2021-02912
Device Sequence Number1
Product Code HWC
UDI-Device Identifier00888867023703
UDI-Public00888867023703
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K061863
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSUTURE ANCHOR, CORKSCREW FT II
Device Catalogue NumberAR-1928SF-2
Device Lot Number12129266
Was Device Available for Evaluation? No
Date Manufacturer Received03/30/2021
Date Device Manufactured11/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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