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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HOOK CEV2295A 3PK N5 FOR HOOK HANDLE; PFM16
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INTEGRA MICROFRANCE S.A.S. HOOK CEV2295A 3PK N5 FOR HOOK HANDLE; PFM16 Back to Search Results
Catalog Number CEV2295A
Device Problem Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported the sheath of the hook handle ((b)(4)) melted during surgery.No further information has been provided.
 
Event Description
N/a.
 
Manufacturer Narrative
Failure analysis - the hook was returned for evaluation and the evaluation verified the complaint as valid.The coating is melted at the distal part.The coating has not been performed at integra: it is green instead of blue.The etching is erased.The device has been repaired outside of integra.Root cause - the instrument has been repaired / modified outside of integra by an external contractor.This modification could weaken the instrument and led to the reported event.
 
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Brand Name
HOOK CEV2295A 3PK N5 FOR HOOK HANDLE
Type of Device
PFM16
Manufacturer (Section D)
INTEGRA MICROFRANCE S.A.S.
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saint aubin le monial 03160
FR  03160
MDR Report Key10715799
MDR Text Key212542287
Report Number2523190-2020-00123
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
PMA/PMN Number
K993655
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCEV2295A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2020
Date Manufacturer Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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