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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT UNIVERSAL BROACH HANDLE; HIP INSTRUMENTS : HANDLES
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DEPUY ORTHOPAEDICS INC US SUMMIT UNIVERSAL BROACH HANDLE; HIP INSTRUMENTS : HANDLES Back to Search Results
Model Number 2570-00-000
Device Problems Corroded (1131); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
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 instruments were reported due to corrosion and wear.No surgical delay.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned instrument partially 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
SUMMIT UNIVERSAL BROACH HANDLE
Type of Device
HIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11497386
MDR Text Key243717733
Report Number1818910-2021-05223
Device Sequence Number1
Product Code HTQ
UDI-Device Identifier10603295142843
UDI-Public10603295142843
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 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2570-00-000
Device Catalogue Number257000000
Device Lot NumberKA0706
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2021
Date Manufacturer Received04/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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