MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC PRI SPACER BLOCK; PRSTHSIS, KNEE, FEMRTIBIL, CMNTD, MTL/PLYMR

Model Number	71441265
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Result of investigation: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The white rings on the device are fractured and missing, rendering the device inoperable.The device was manufactured in 2014 and shows signs of extensive use.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary. we consider this investigation closed.
Event or Problem Description
It was reported, that during tka the white o rings are gone and will not hold on clip on build ups.The procedure finished with the same device.No surgical delay.No patient harm.

• Brand Name: GII SPC PRI SPACER BLOCK
• Common Device Name: PRSTHSIS, KNEE, FEMRTIBIL, CMNTD, MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10837290
• Report Number: 1020279-2020-06429
• Device Sequence Number: 11712033
• Product Code: HRY
• UDI-Device Identifier: 00885556034354
• UDI-Public: 00885556034354
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

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: No Information
• Device Model Number: 71441265
• Device Catalogue Number: 71441265
• Device Lot Number: 14AM01009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/13/2020
• Patient Sequence Number: 1