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 08/31/2016

Event Type  malfunction  

Event Description

On inspection, the moving piece of the guide was seen to be broken off.

Manufacturer Narrative

One polarstem collar reamer guide, used in treatment, was returned for evaluation.Visual inspection reveals that the hook has fractured around the metal pin and is separated from the rest of the device.The spring holding the hook in position was not returned.Dents are observed at several location of the hook.Material analysis revealed that the fracture happened due to overloading.A review of the production documentation did not reveal any deviation from the standard manufacturing processes.Dimensional evaluation of the relevant design features did not detect any dimensional deviation.A review of complaint history identified however two complaints with a similar failure mode.A review of the design was performed.It was observed that the hook may contact the reamer if it is not fully engaged in the rasp during reaming.Functional evaluation with reference parts showed that this failure mode is compatible with the dents observed on the returned hook.Based on the performed investigation it is assumed that foreign material prevented the hook to fully engage in 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 insufficient design specifications.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.Smith and nephew will monitor this device for further similar issues.The device will be archived.

• 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: 10180083
• MDR Text Key: 195961745
• Report Number: 9613369-2020-00122
• 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: A57539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• 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: Reuse
• Removal/Correction Number: Z-2827-2020
• Patient Sequence Number: 1