MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STRUT MEDIUM; PIN, FIXATION, THREADED

Model Number 71070220

Device Problems Device Markings/Labelling Problem (2911); Naturally Worn (2988)

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

Event Date 04/12/2021

Event Type  malfunction  

Event Description

It was reported that the five of the strut medium are wearing causing numbers to be unreadable.It is unknown whether the event happened and if there was a patient involvement.

Manufacturer Narrative

H3, h6:the device, intended for use in treatment was returned for evaluation: a visual inspection was conducted and confirmed the numbers on the strut medium are wearing causing them to become unreadable.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: STRUT MEDIUM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11797374
• MDR Text Key: 249702835
• Report Number: 1020279-2021-03903
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 03596010291028
• UDI-Public: 03596010291028
• Combination Product (y/n): N
• PMA/PMN Number: K994143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71070220
• Device Catalogue Number: 71070220
• Device Lot Number: 11ASM0138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Date Manufacturer Received: 10/07/2021
• Patient Sequence Number: 1