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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR REAMER GUIDE PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

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SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR REAMER GUIDE PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT Back to Search Results
Catalog Number 75102205
Device Problem Break
Event Date 11/19/2019
Event Type  Injury  
Event Description

It was reported this instrument broke and is no longer functioning properly. Device broke outside the patient 's wound and no pieces fell inside the wound. No delay to procedure. No injury to patient. S&n backup was available.

 
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Brand NamePOLARSTEM COLLAR REAMER GUIDE
Type of DevicePROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
baar 06340
SZ  06340
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH500 0
SZ  CH5000
Manufacturer Contact
sarah freestone
oberneuhofstrasse 10d
baar  06340
  06340
0447940038
MDR Report Key10181776
Report Number9613369-2020-00127
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/22/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number75102205
Device LOT NumberA58660
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/07/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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