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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE ACORNREAM 10MM THIN *EA; CANNULATED SURGICAL DRILL
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DEPUY MITEK LLC US RESTORE ACORNREAM 10MM THIN *EA; CANNULATED SURGICAL DRILL Back to Search Results
Model Number 219335
Medical Device Problem Code Degraded (1153)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/24/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported by the sales rep that during an unknown procedure on (b)(6) 2021, it was observed that acorn reamer thin shaft device was dull.Another like device was used to complete the procedure with a delay of 1-2 minutes.There were no adverse patient consequences reported.No additional information was provided.
 
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Common Device Name
CANNULATED SURGICAL DRILL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key12128516
Report Number1221934-2021-02107
Device Sequence Number19731123
Product Code HTO
UDI-Device Identifier10886705005802
UDI-Public10886705005802
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/24/2021
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 Model Number219335
Device Catalogue Number219335
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/24/2021
Initial Report FDA Received Date07/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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