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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CALCAR PLANER-SMALL; HIP INSTRUMENTS : REAMERS
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DEPUY ORTHOPAEDICS INC US SUMMIT CALCAR PLANER-SMALL; HIP INSTRUMENTS : REAMERS Back to Search Results
Model Number 2570-04-100
Device Problem Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
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
Calcar planer reported to be scuffed.
 
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.Device history review: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
SUMMIT CALCAR PLANER-SMALL
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11796686
MDR Text Key249672333
Report Number1818910-2021-09869
Device Sequence Number1
Product Code LYS
UDI-Device Identifier10603295143178
UDI-Public10603295143178
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 04/26/2021
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
Device Operator Health Professional
Device Model Number2570-04-100
Device Catalogue Number257004100
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/26/2021
Initial Date FDA Received05/10/2021
Supplement Dates Manufacturer Received06/21/2021
Supplement Dates FDA Received06/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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