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	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Piece broken off, do not have that piece to return.The piece was retrieved but was lost in the decontamination process in spd.[nil, (b)(6) 2017] confirmation that the spring was removed from the wound and following statement received: "the surgeon reamed the calcar then could not disengage the neck.It broke while trying to dislodge it from the broach.The calcar reaming process in the polar stem is cumbersome.".
Additional Manufacturer Narrative
One polarstem collar reamer guide, used in treatment, was returned for evaluation.Visual inspection reveals that the whole hook and the spring are missing.It was reported that the hook broke off after calcar reaming.All missing parts including the device spring were reported to have been removed from the wound.A review of the production documentation did not reveal any deviation from the standard manufacturing processes.A review of complaint history identified one complaint with a similar failure mode for this batch of products.A thorough medical assessment could not be performed as no further medical documents were available.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 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 returned part will be archived.

• 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: 10180009
• Report Number: 9613369-2020-00121
• Device Sequence Number: 3053588
• Product Code: LZO
• UDI-Device Identifier: 00885556535493
• UDI-Public: (01)00885556535493(10)A57539
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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?: Yes
• Is this a Product Problem Report?: No
• 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: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 08/02/2017; 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown