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	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) ref# (b)(4): this is a loaner kit complaint and it was found during inspection at our warehouse.The movement part of the reamer guide is raising out of the main body, so it makes the device difficult to attach to the calcar reamer.The device will be returned for evaluation.
Additional Manufacturer Narrative
A complaint was reported due to the protrusion of the trigger of the hook mechanism on a polarstem reamer guide.Visual inspection confirmed the reported issue.Additionally numerous scratch marks are visible on the surface where the reamer guide and the reamer are in contact.A dimensional evaluation did not detect any deviation from the essential dimension requirements.A tolerance analysis performed could however not exclude the possibility of a protrusion of the hook mechanism even in the case where all essential dimension requirements are met.There is however no indication that the reported issue could affect the surgery being performed.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.

• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH500 0; SZ CH5000
• Manufacturer Contact: sarah freestone ; oberneuhofstrasse 10d; baar 06340 ; SZ 06340 ; 0447940038246
• MDR Report Key: 10180059
• Report Number: 9613369-2020-00123
• Device Sequence Number: 11526415
• Product Code: LZO
• UDI-Device Identifier: 00885556535493
• UDI-Public: (01)00885556535493(10)A61590
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 75102205
• Device Catalogue Number: 75102205
• Device Lot Number: A61590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 07/13/2020; 09/01/2022; 09/01/2022
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/18/2020; 09/02/2022; 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2827-2020
• Patient Sequence Number: 1
• Patient Sex: Unknown