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

Model Number 71441265

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

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 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
• Type of Device: PRSTHSIS, KNEE, FEMRTIBIL, CMNTD, MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116
• MDR Report Key: 10837290
• MDR Text Key: 216174589
• Report Number: 1020279-2020-06429
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556034354
• UDI-Public: 00885556034354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1