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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC STR CUP IMPACTOR; HIP INSTRUMENTS : IMPACTORS
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DEPUY ORTHOPAEDICS INC US DURALOC STR CUP IMPACTOR; HIP INSTRUMENTS : IMPACTORS Back to Search Results
Model Number 2360-71-000
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 06/03/2020
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 this patient had a right total hip.During impaction of the cup, the impaction handle broke.All pieces were found.Surgical delay of 30 minutes.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
 
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Brand Name
DURALOC STR CUP IMPACTOR
Type of Device
HIP INSTRUMENTS : IMPACTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10174943
MDR Text Key195776743
Report Number1818910-2020-14161
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295119906
UDI-Public10603295119906
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 06/03/2020
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 Number2360-71-000
Device Catalogue Number236071000
Device Lot NumberSO2028280
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Initial Date Manufacturer Received 06/03/2020
Initial Date FDA Received06/19/2020
Supplement Dates Manufacturer Received06/24/2020
Supplement Dates FDA Received06/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age55 YR
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