MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RULER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71674079

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2020

Event Type  malfunction  

Event Description

It was reported that upon inspection the threads were seem to be broken.No case involved.

Manufacturer Narrative

The device, intended for use in treatment, was return for evaluation.Our investigation included a visual inspection of the device and confirmed the nuts are broken on the rulers which confirmed the stated failure mode.This failure mode has been previously identified.Since the manufacturing of the complaint device, a design change was implemented to eliminate/reduce the occurrence of this failure.Only the outside of the ruler was returned.The lot number is unreadable on the device.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.

• Brand Name: RULER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10188576
• MDR Text Key: 196224779
• Report Number: 1020279-2020-02695
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560759
• UDI-Public: 03596010560759
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71674079
• Device Catalogue Number: 71674079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1