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	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A polarstem collar reamer guide (75102205), used in treatment, was received for evaluation.It was reported that the device failed during the procedure, when the reamer got caught on the reamer guide.It was confirmed, in an additional information request, that the device broke, however no pieces fell inside the wound.A visual analysis could confirm the reported failure mode.The hook and the spring of the device are missing.The rear part of the hook is still attached to the pin of the reamer guide.The production documentation was reviewed, however there were no deviations found.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 cantilever 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 intraoperatively.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 actions were started to evaluate the risk of this device.Should the device be returned, this complaint will be reassessed.Smith and nephew will monitor this version of the device for further similar issues.The device will be discarded.
Event or Problem Description
It was reported that during inspection the item clip and spring broke apart.No case involved.
Additional Manufacturer Narrative
A polarstem collar reamer guide (75102205), used in treatment, was received for evaluation.It was reported that the device failed during the procedure, when the reamer got caught on the reamer guide.It was confirmed, in an additional information request, that the device broke, however no pieces fell inside the wound.A visual analysis could confirm the reported failure mode.The hook and the spring of the device are missing.The rear part of the hook is still attached to the pin of the reamer guide.The production documentation was reviewed, however there were no deviations found.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 collision might lead to a fracture of the hook and the spring can 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 intraoperatively.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.Smith and nephew will monitor this version of the device for further similar issues.The 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
• 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: 10181758
• Report Number: 9613369-2020-00128
• Device Sequence Number: 14216365
• Product Code: LZO
• UDI-Device Identifier: 00885556535493
• UDI-Public: 00885556535493
• 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?: 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: 05/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/09/2020
• 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: A
• 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