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

Catalog Number 75102205

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

Event Description

It was reported that the metal on reamer guide is chipped.This was identified during standard office inspection.No surgery or patient involved.

Manufacturer Narrative

A polarstem collar reamer guide (75102205), used in treatment was received for evaluation.It was reported that the device was broken.The analysis showed that the moving piece broke.The rear part is still attached to the pin, however the hook and the spring of the part are missing.A visual analysis and a device history review, which showed no deviations, were performed.Additional information was requested regarding the missing parts.No relationship between these missing pieces and any surgery was reported.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 the spring might become loose.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 during reaming.A new design of the device has been released in order to prevent the reoccurrence of this issue.The root cause is attributed to a insufficient design.Further investigations have been initiated to review the performance of this device.This complaint has been reopened for reporting reasons, according to the current procedure.No additional information became available.This version of the device will be monitored for similar issues.The device will be discarded.

• Brand Name: POLARSTEM COLLAR REAMER GUIDE
• Type of Device: PROSTH, 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 ; SZ 06340 ; 0447940038
• MDR Report Key: 10181760
• MDR Text Key: 196056389
• Report Number: 9613369-2020-00126
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75102205
• Device Lot Number: A58660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• 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: A
• Removal/Correction Number: Z-2827-2020
• Patient Sequence Number: 1