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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CUP IMPACTOR TIP 28MM; HIP INSTRUMENTS : INSERTION DEVICES
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DEPUY ORTHOPAEDICS INC US PINN CUP IMPACTOR TIP 28MM; HIP INSTRUMENTS : INSERTION DEVICES Back to Search Results
Model Number 2217-50-006
Device Problem Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
(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
Instruments were reported as 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.
 
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Brand Name
PINN CUP IMPACTOR TIP 28MM
Type of Device
HIP INSTRUMENTS : INSERTION DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11274452
MDR Text Key230234906
Report Number1818910-2021-02364
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295098959
UDI-Public10603295098959
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 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2217-50-006
Device Catalogue Number221750006
Was Device Available for Evaluation? No
Date Manufacturer Received03/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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