MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MI IN SLT 3 MO TI CU BL LT; PRSTH,KN,PTLL/FMRTBL,SM-CNSTR,UNCMN,PRS,CTD,PLY/MTL

Model Number	71441136
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, when the cut block was tightened into the tibial guide, the set screw broke leaving the cut block affixed to the guide and not removable until after the case with a punch and a mallet.There was no delay to the case.Replacement required.
Event or Problem Description
It was reported that during surgery, when the cut block was tightened into the tibial guide, the set screw broke leaving the cut block affixed to the guide and not removable until after the case with a punch and a mallet.There was no delay to the case.The broken part was outside of the patient incision, it didn't represent a potential harm to the patient.The surgery was not affected as the tibial guide could still be used during the case just fine.
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 after reviewing the complaint and the results of investigation it was determined that this device breakage doesn't represent a potential impact to the patient, as the broken part it's outside of 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 MI IN SLT 3 MO TI CU BL LT
• Common Device Name: PRSTH,KN,PTLL/FMRTBL,SM-CNSTR,UNCMN,PRS,CTD,PLY/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9639862
• Report Number: 1020279-2020-00407
• Device Sequence Number: 502185
• Product Code: MBH
• UDI-Device Identifier: 03596010484086
• UDI-Public: 03596010484086
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: 71441136
• Device Catalogue Number: 71441136
• Device Lot Number: 06JM01547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1