MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SLT 3 MOD TIB CUTBLCK RT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number 71440205

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

Event Description

It was reported that, during setup or inspection it was noticed that these instruments showed an overabundance of bio-film that has built up on the instruments over the years.No case reported; therefore, there was no patient involvement.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The returned device has foreign debris embedded on the exterior surface rendering it inoperable.The device also shows signs of extensive use.A review of complaint history did not reveal additional complaint.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII SLT 3 MOD TIB CUTBLCK RT
• Type of Device: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• 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 road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11580411
• MDR Text Key: 243210002
• Report Number: 1020279-2021-02420
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010460424
• UDI-Public: 03596010460424
• 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
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2013
• Device Model Number: 71440205
• Device Catalogue Number: 71440205
• Device Lot Number: 03JM08025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1