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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CALCAR PLANER SML; REAMERS
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DEPUY ORTHOPAEDICS INC US MODULAR CALCAR PLANER SML; REAMERS Back to Search Results
Model Number 2570-04-501
Device Problem Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/13/2021
Event Type  malfunction  
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.
 
Event Description
It was reported that the planers are dull and need replacing.Ship to (b)(6).No surgical delay.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
MODULAR CALCAR PLANER SML
Type of Device
REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11884103
MDR Text Key256276072
Report Number1818910-2021-11188
Device Sequence Number1
Product Code HWE
UDI-Device Identifier10603295482024
UDI-Public10603295482024
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2570-04-501
Device Catalogue Number257004501
Was Device Available for Evaluation? No
Date Manufacturer Received06/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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