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

Model Number 71441265

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2020

Event Type  Injury  

Event Description

It was reported that during surgery, while outside the patient, device was noticed to have the plastic gasket broken.Procedure was concluded using a double sided spacer block.There was no injury or delay.

Manufacturer Narrative

Ave broken.Per complaint details, the procedure was concluded using a double sided spacer block.There was no patient injury or delay reported.Therefore, since no patient harm is alleged, no further clinical assessment is warranted.A visual inspection confirmed the plastic rings are broken on the gii spc pri spacer block.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GII SPC PRI SPACER BLOCK
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10539585
• MDR Text Key: 207102584
• Report Number: 1020279-2020-04607
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556034354
• UDI-Public: 00885556034354
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71441265
• Device Catalogue Number: 71441265
• Device Lot Number: 07KM10263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention