MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR REAMER GUIDE; PROSTHESIS,HIP,SEMI-CNSTRND,METAL/CERAMIC/POLY,CEMENTED OR NON-POROUS,UNCEMENTED

Model Number	75102205
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure and inside of the patient the spring mechanism of the polarstem collar reamer guide broke while in use.Surgical delay was greater than 30 min and it is not known how the procedure was finished.
Additional Manufacturer Narrative
A polarstem collar reamer guide (75102205), used in treatment, was received for evaluation.It was reported that during procedure and inside of the patient the spring mechanism of the polarstem collar reamer guide broke while in use.Surgical delay was greater than 30 minutes.A visual analysis could confirm that the hook of the reamer guide is broken apart.All pieces including the spring were returned for evaluation.The reamer guide shows some minor signs of use.The production documentation was reviewed, 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 to the rasp during reaming.This collision might lead to a fracture of the hook and the spring can become loose.However a breakage was not reported in this case.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.A field action was started to remove some batches of this instrument, including the one in scope, from the market.Smith and nephew will monitor this version of the device for further similar issues.The returned device will be archived.
Additional Manufacturer Narrative
Additional information included according to capa-648.
Additional Manufacturer Narrative
H3, h6: a polarstem collar reamer guide (75102205), used in treatment, was received for evaluation.It was reported that during procedure and inside of the patient the spring mechanism of the polarstem collar reamer guide broke while in use.Surgical delay was greater than 30 minutes.A visual analysis could confirm that the hook of the reamer guide is broken apart.All pieces including the spring were returned for evaluation.The reamer guide shows some minor signs of use.The production documentation was reviewed, 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 to the rasp during reaming.This collision might lead to a fracture of the hook and the spring can become loose.However a breakage was not reported in this case.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.A field action was started to remove some batches of this instrument, including the one in scope, from the market.Smith and nephew will monitor this version of the device for further similar issues.The returned device will be archived.

• Brand Name: POLARSTEM COLLAR REAMER GUIDE
• Common Device Name: PROSTHESIS,HIP,SEMI-CNSTRND,METAL/CERAMIC/POLY,CEMENTED OR NON-POROUS,UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: sarah freestone ; schachenallee 29; aarau ; SZ ; 0447940038246
• MDR Report Key: 10364018
• Report Number: 9613369-2020-00152
• Device Sequence Number: 2927038
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 09/18/2020; 09/05/2022; 09/05/2022
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/21/2020; 09/07/2022; 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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