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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRPTR RGNSRB STR ANCHR W/1ULTRBRDSTRBL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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MICRPTR RGNSRB STR ANCHR W/1ULTRBRDSTRBL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Back to Search Results
Model Number 72204983
Medical Device Problem Codes Premature Activation (1484); Unintended Movement (3026)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/03/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
 
Event or Problem Description
It was reported that, during an instability shoulder surgery, the "2.0mm microraptor regenesorb suture anchor" has pulled out from the inserter while deploying.The procedure was successfully completed without delay using a back-up device into the same bone hole.No patient injuries or other complications were reported.
 
Additional Manufacturer Narrative
Internal complaint reference (b)(4) not reportable event.H1, h6: updated.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Per additional information provided, the anchor pulled out from the inserter (and not from the bone) and the back-up device was used in the same bone hole; therefore the procedure was completed as intended with no medical intervention required or injury to the patient.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details.
 
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Brand Name
MICRPTR RGNSRB STR ANCHR W/1ULTRBRDSTRBL
Common Device Name
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
MDR Report Key12516317
Report Number1219602-2021-02115
Device Sequence Number17435557
Product Code MAI
UDI-Device Identifier00885556710302
UDI-Public00885556710302
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K180361
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/04/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date05/06/2022
Device Model Number72204983
Device Catalogue Number72204983
Device Lot Number50804024
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 09/03/2021
Supplement Date Received by Manufacturer10/29/2021
Initial Report FDA Received Date09/22/2021
Supplement Report FDA Received Date11/04/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured05/06/2019
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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