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

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2018

Event Type  Injury  

Event Description

It was reported that the device failed upon inspection in office.No patient involve.

Manufacturer Narrative

It was reported that the device failed upon inspection in office.The part, used in treatment, was not returned for investigation.No batch number was communicated, no review of similar complaints or of the production records could be performed.No further information are available as no precise description of the reported issue could be obtained, the reported failure mode cannot be confirmed.No thorough investigation can be performed and the root cause of the reported issue remains undetermined.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
• Type of Device: 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: 10180070
• MDR Text Key: 195962011
• Report Number: 9613369-2020-00125
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00885556535493
• UDI-Public: 00885556535493
• Combination Product (y/n): N
• PMA/PMN Number: K143739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75102205
• Device Catalogue Number: 75102205
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1