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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PROX NECK TRL 45MM; RECLAIM INSTRUMENTS : FEMORAL TRIALS
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DEPUY IRELAND - 9616671 RECLAIM PROX NECK TRL 45MM; RECLAIM INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Model Number 2975-31-045
Device Problem Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 01/01/2020
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
T handles broken, reclaim neck broken.No surgical delay or patient consequences reported.
 
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
RECLAIM PROX NECK TRL 45MM
Type of Device
RECLAIM INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10574381
MDR Text Key208166091
Report Number1818910-2020-20747
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295156376
UDI-Public10603295156376
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2975-31-045
Device Catalogue Number297531045
Was Device Available for Evaluation? No
Date Manufacturer Received11/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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