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	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device failed upon inspection in office.No patient involve.
Additional 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
• 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
• MDR Report Key: 10180070
• Report Number: 9613369-2020-00125
• Device Sequence Number: 3053589
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2020

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: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1