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

Model Number	75102205
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
A polarstem collar reamer guide, used in treatment, was returned for investigation.The hook of the reamer guide was confirmed to be broken.A design review previously performed 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 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 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 returned device will be discarded.

• Brand Name: POLARSTEM COLLAR REAMER GUIDE
• Common Device Name: 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
• MDR Report Key: 10180067
• Report Number: 9613369-2020-00124
• Device Sequence Number: 14216364
• Product Code: LZO
• UDI-Device Identifier: 00885556535493
• UDI-Public: (01)00885556535493(17)421204(10)A57539
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2020

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
• Operator of Device: Health Professional
• Device Model Number: 75102205
• Device Catalogue Number: 75102205
• Device Lot Number: A57539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 08/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1