MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRIPPER; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number 71674080

Device Problems Corroded (1131); Material Discolored (1170)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2020

Event Type  Injury  

Event Description

It was reported that the device was not working properly, the nut is rusted.This happened during set up or inspection.There was no delay in the case; but there was a change in the surgical technique.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has rust on the nut, rendering the device inoperative.The device shows signs of extensive use.Evaluation of the returned gripper, batch # 18asp0001, revealed the presence of oxygen (o) peaks in the affected areas of the knurled screw.Oxygen peaks were also observed on the surface o the adjustable link.Large peaks for oxygen (o) are consistent with the presence of rust on iron (fe) based components.This suggest that the rust-like discoloration on the knurled screw is rust.The clinical/medical evaluation concluded that per complaint details, the device malfunctioned during set up or inspection, the nut was rusted.One photo provided confirmed the reported failure.Based on the information provided, there was no surgical delay or patient injury/impact as the procedure was completed with a change in surgical technique; therefore, no further medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are 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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GRIPPER
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10115585
• MDR Text Key: 193699072
• Report Number: 1020279-2020-01972
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 03596010560766
• UDI-Public: 3596010560766
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71674080
• Device Lot Number: 18ASP0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention