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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE

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DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE Back to Search Results
Catalog Number 210133
Device Problems Migration or Expulsion of Device; Material Twisted/Bent
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4). The lot number is unknown.

 
Event Description

It was reported by the affiliate via cst that the rigidfix fem 3. 3 mm has been rejected by the patient. It had to be removed through the popliteal muscle causing a scar in that area. Additional information received from the affiliate reported the lot number is unknown and the procedure occurred about 2 months ago. The affiliate also reported the events reported did not occur during the procedure but some time after.

 
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Brand NameRIGIDFIX FEM 3.3MM S/T XPIN
Type of DeviceSOFT-TISSUE ANCHOR, BIOABSORBABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham , MA 02767
6103142063
MDR Report Key8793315
Report Number1221934-2019-57669
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/16/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number210133
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/07/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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