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 11/19/2019

Event Type  malfunction  

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.

Manufacturer Narrative

A polarstem collar reamer guide (75102205), used in treatment, was received for evaluation.It was reported that the device broke and is no longer functional.The device broke outside the patient, no pieces fell inside the wound.The visual 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.The production documentation was reviewed, however there were no deviations found.Additional information was requested regarding the missing parts.It was reported that the two pieces broken off were disposed.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 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 during reaming.A new design of the device has been released in order to prevent the reoccurrence of this issue.The failure mode can be confirmed, 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 version of the device for further similar issues.The returned 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: 10181776
• MDR Text Key: 196056677
• Report Number: 9613369-2020-00127
• 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: Physician
• 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

• 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: 01/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/13/2020; 09/01/2022; 09/01/2022
• Supplement Dates FDA Received: 07/18/2020; 09/02/2022; 09/15/2022
• 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