MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC PRI SPACER BLOCK; PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,METAL/POLYMER

Model Number	71441265
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the white o rings are gone and device would not hold on clip on build ups.There was no delay and no injury.It's unknown how the procedure concluded.
Additional Manufacturer Narrative
After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that, during surgery, it was noticed that the white o rings were gone and the device would not hold on clip on build ups.There was no delay and no injury.It's unknown how the procedure concluded.However after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable, since this event did not cause any injury and it would not be likely to cause or contribute to a death or serious injury that if the device malfunction were to recur.

• Brand Name: GII SPC PRI SPACER BLOCK
• Common Device Name: PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10558491
• Report Number: 1020279-2020-04742
• Device Sequence Number: 13767482
• Product Code: HRY
• UDI-Device Identifier: 00885556034354
• UDI-Public: 00885556034354
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/19/2021

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: 71441265
• Device Catalogue Number: 71441265
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1