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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN STRAIGHT CUP IMPACTOR; HIP INSTRUMENTS : IMPACTORS
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DEPUY ORTHOPAEDICS INC US PINN STRAIGHT CUP IMPACTOR; HIP INSTRUMENTS : IMPACTORS Back to Search Results
Model Number 2217-50-041
Device Problems Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problem No Code Available (3191)
Event Date 07/13/2020
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 had a problem threading the cup inserter in to the cup.Looks to have a burr on the end of the threads.There was 1 minute 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
PINN STRAIGHT CUP IMPACTOR
Type of Device
HIP INSTRUMENTS : IMPACTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10326520
MDR Text Key200426320
Report Number1818910-2020-16903
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295098980
UDI-Public10603295098980
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 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2217-50-041
Device Catalogue Number221750041
Was Device Available for Evaluation? No
Date Manufacturer Received09/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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