MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PATELLAR REAMER SHAFT; PRSTHSIS, KNEE, PTLL/FMRTL, SM-CNSTRND, UNCNTD, PRS, CTD, PLYMR/MTL/PLYMR

Model Number	71440324
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the bottom of the reamer shaft broke off.All pieces were recovered during surgery and there was no harm to the patient.No delay to the patient because a s&n back up device was available.
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 the device broke outside of the patient and no pieces fell inside the patient, 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: GII PATELLAR REAMER SHAFT
• Common Device Name: PRSTHSIS, KNEE, PTLL/FMRTL, SM-CNSTRND, UNCNTD, PRS, CTD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9805997
• Report Number: 1020279-2020-00818
• Device Sequence Number: 654004
• Product Code: MBH
• UDI-Device Identifier: 03596010214997
• UDI-Public: 03596010214997
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: No Information
• Device Model Number: 71440324
• Device Catalogue Number: 71440324
• Device Lot Number: 13EM18039
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1