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

Model Number 71441265

Device Problem Component Missing (2306)

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

Event Date 08/25/2020

Event Type  malfunction  

Event 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.Procedure conclude with the same device.

Manufacturer Narrative

Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection confirmed the rings are missing from 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.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.

• Brand Name: GII SPC PRI SPACER BLOCK
• Type of Device: PRSTHSS,KNEE,FEMOROTIBIAL,SM-CONSTRAINED,CMNTD,METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10558538
• MDR Text Key: 207700526
• Report Number: 1020279-2020-04744
• 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: 11/10/2020

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: Health Professional
• Device Model Number: 71441265
• Device Catalogue Number: 71441265
• Device Lot Number: 09BM03858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1