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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE ACORNREAM 6MM THIN *EA CANNULATED SURGICAL DRILL

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DEPUY MITEK LLC US RESTORE ACORNREAM 6MM THIN *EA CANNULATED SURGICAL DRILL Back to Search Results
Model Number 219336
Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2020
Event Type  Malfunction  
Manufacturer Narrative

Udi: (b)(4). The lot number was unknown. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.

 
Event Description

It was reported by the affiliate in (b)(6) that a 6mm acorn reamer device was bent and got stuck inside a handpiece device. There was no procedure nor patient involvement reported. No additional information was provided.

 
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Type of DeviceCANNULATED SURGICAL DRILL
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
6013142063
MDR Report Key11170263
MDR Text Key226800804
Report Number1221934-2021-00104
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/14/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number219336
Device Catalogue Number219336
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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