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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORKSCREW FT, PEEK, SUTURETAPE, 4.75M; SCREW, FIXATION, BONE
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CORKSCREW FT, PEEK, SUTURETAPE, 4.75M; SCREW, FIXATION, BONE Back to Search Results
Model Number CORKSCREW FT, PEEK, SUTURETAPE, 4.75M
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/03/2021
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
On (b)(6) 2021 it was reported by a sales representative via email that an ar-1927pst-475 suture anchor is broken and could not be used.The surgeon followed the correct procedures in order to insert the corkscrew.It was safely removed and saved to be returned back to arthrex.The patient was not harmed during the insertion or removal of the device.This was discovered during use.Additional information provided on 09/09/2021 the procedure was an arthroscopic rtc repair.The device broke upon insertion, after preparing a proper bone socket.The broken device was retrieved and then another device was inserted.
 
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Brand Name
CORKSCREW FT, PEEK, SUTURETAPE, 4.75M
Common Device Name
SCREW, FIXATION, BONE
MDR Report Key12623351
Report Number1220246-2021-03794
Device Sequence Number3991202
Product Code HWC
UDI-Device Identifier00888867237872
UDI-Public00888867237872
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K061863
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 10/13/2021
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 Expiration Date04/30/2026
Device Model NumberCORKSCREW FT, PEEK, SUTURETAPE, 4.75M
Device Catalogue NumberAR-1927PST-475
Device Lot Number13310352
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/03/2021
Initial Report FDA Received Date10/13/2021
Date Device Manufactured05/13/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Usage of Device Initial
Patient Sequence Number1
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