MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI OFFSET REF IMP SD SHAFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71364023

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2020

Event Type  malfunction  

Event Description

It was reported that the surgeon states that this driver when attaching the cup is stripping.No delay to procedure, no injury to patient.S&n backup was available.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirmed the hex tip is stripped causing stated failure.The device was manufactured in 2018.The device show significant signs of wear/usage.A review of complaint history on the listed part revealed no prior complaints for the listed batch number with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality 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.Expected wear/tear is likely the probable cause 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.

• Brand Name: MI OFFSET REF IMP SD SHAFT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10015509
• MDR Text Key: 189562972
• Report Number: 1020279-2020-01426
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010479136
• UDI-Public: 03596010479136
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• 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: 06/26/2020

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: 71364023
• Device Catalogue Number: 71364023
• Device Lot Number: 18JM19700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/30/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1