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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 6 RT PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL

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SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 6 RT PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL Back to Search Results
Model Number 71433356
Device Problems Break (1069); Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 08/31/2020
Event Type  Malfunction  
Event Description

It was reported that the femoral trials were found cracked. This was discovered after the case. No patient was affected or delays were reported.

 
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Brand NameGII SPC REAMTHRU CR TR SZ 6 RT
Type of DevicePRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
1450 brooks rd.
memphis, TN 38116
5123913905
MDR Report Key10587991
MDR Text Key208583402
Report Number1020279-2020-04867
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number71433356
Device Catalogue Number71433356
Device LOT Number11AM11415
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/21/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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