MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM KNOCK PLATE LARGE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75102238
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon states that when the mallet hits the polar broach handle strike plates, metal flakes go flying.No delay to procedure, no injury to patient.S&n backup was available.No closure letter needed.Device will be returned.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that no pieces fell inside the patient's incision, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: POLARSTEM KNOCK PLATE LARGE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9608470
• Report Number: 9613369-2020-00014
• Device Sequence Number: 2641938
• Product Code: JDI
• UDI-Device Identifier: 00885556535417
• UDI-Public: 00885556535417
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: 75102238
• Device Catalogue Number: 75102238
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1