MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF AP CT BLK 7; PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CMNTD,METAL/POLYMER

Model Number	71441155
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the chamfer of cutting block broke off of.No case involved.
Additional Manufacturer Narrative
Results of investigation: the device, intended for use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GII MIS DCF AP CT BLK 7
• Common Device Name: PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CMNTD,METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10546555
• Report Number: 1020279-2020-04606
• Device Sequence Number: 19616625
• Product Code: HRY
• UDI-Device Identifier: 03596010497239
• UDI-Public: 03596010497239
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 71441155
• Device Catalogue Number: 71441155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1