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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PEGA MEDICAL INC FASIER DUVAL TELESCOPIC IM SYSTEM; FEMALE RETRIEVER Ø3.2MM
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PEGA MEDICAL INC FASIER DUVAL TELESCOPIC IM SYSTEM; FEMALE RETRIEVER Ø3.2MM Back to Search Results
Model Number FRT100
Medical Device Problem Codes Difficult to Insert (1316); Failure to Align (2522); Defective Device (2588)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/11/2020
Type of Reportable Event Malfunction
Event or Problem Description
Surgeon informed that during surgery in a patient with congenital pseudarthrosis, for replacing an existing fassier duval nail by a larger one, the female retriever (frt100) used for the removal presented a misalignment of the two halves, causing that the instrument did not fit with the hex hole of the implant to be removed.
 
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Brand Name
FASIER DUVAL TELESCOPIC IM SYSTEM
Common Device Name
FEMALE RETRIEVER Ø3.2MM
Manufacturer (Section D)
PEGA MEDICAL INC
1111 autoroute chomedey
laval, quebec H7W 5 J8
CA  H7W 5J8
MDR Report Key10236693
Report Number3000327445-2020-00004
Device Sequence Number2623695
Product Code LXH
UDI-Device Identifier07540194007193
UDI-Public(01)07540194007193
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/06/2020
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
Operator of Device Health Professional
Device Model NumberFRT100
Device Catalogue NumberFRT100
Device Lot Number160512-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/14/2020
Initial Report FDA Received Date07/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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