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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
Model Number 75102205
Device Problem Break
Event Date 05/31/2018
Event Type  Injury  
Event Description

Primary - dr used the instrument with the hook being broke off but requested it be replaced. No delay & the patient was not affected. Rep is uncertain how it broke.

 
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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 Key10180067
Report Number9613369-2020-00124
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/22/2020
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 MODEL Number75102205
Device Catalogue Number75102205
Device LOT NumberA57539
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/10/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
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 Reuse

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