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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 03/09/2020
Event Type  Injury  
Manufacturer Narrative

A polarstem collar reamer guide (75102205), used in treatment, was received for evaluation. It was reported that the device failed during the procedure, when the reamer got caught on the reamer guide. It was confirmed, in an additional information request, that the device broke, however no pieces fell inside the wound. A visual analysis could confirm the reported failure mode. The hook and the spring of the device are missing. The rear part of the hook is still attached to the pin of the reamer guide. The production documentation was reviewed, however there were no deviations found. The review of the complaint database showed that similar cases were reported in the past, one of which led to a corrective and preventive action. A design review was performed which demonstrated that the hook may contact the reamer if it is not fully engaged in the rasp during reaming. This is likely to lead to a fracture of the hook and cantilever as reported here. It is therefore assumed that foreign material prevented the hook from fully engaging with the rasp, which led the reamer to hit and fracture the hook intraoperatively. A new design of the device has been released in order to prevent the reoccurrence of this issue. The root cause is attributed to insufficient design specifications. Further actions were started to evaluate the risk of this device. Should the device be returned, this complaint will be reassessed. Smith and nephew will monitor this version of the device for further similar issues. The device will be discarded.

 
Event Description

It was reported that during inspection the item clip and spring broke apart. No case involved.

 
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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 Key10181758
Report Number9613369-2020-00128
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
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 MODEL Number75102205
Device Catalogue Number75102205
Device LOT NumberA57539
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/22/2020
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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