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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PROXIMAL REAMER 24MM; RECLAIM INSTRUMENTS : REAMERS

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DEPUY IRELAND - 9616671 RECLAIM PROXIMAL REAMER 24MM; RECLAIM INSTRUMENTS : REAMERS Back to Search Results
Model Number 2975-24-105
Device Problem Peeled/Delaminated (1454)
Patient Problem Insufficient Information (4580)
Event Date 09/24/2020
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
Reclaim hip revision.(b)(6) 2020.During reaming of the proximal body the loose parts of the couloured rings were noticed.They used extra pulse lavage to decrease the risk of parts in the patient.
 
Manufacturer Narrative
Product complaint # (b)(4).Corrected: b9: date devices returned.H3: device evaluation information.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Corrected: b9: date devices returned.H3: device evaluation information.
 
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
RECLAIM PROXIMAL REAMER 24MM
Type of Device
RECLAIM INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11024750
MDR Text Key222040872
Report Number1818910-2020-27126
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295156239
UDI-Public10603295156239
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/02/2020
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 Number2975-24-105
Device Catalogue Number297524105
Device Lot NumberSO2006676
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2020
Initial Date Manufacturer Received 12/02/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received12/02/2020
01/21/2021
Supplement Dates FDA Received12/16/2020
01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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