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

The associated device, intended for use, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has scratches and nicks making it difficult to read the ruler, rendering the device inoperative.A review of complaint history did not reveal additional complaints for the listed batch.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.Damage from misuse or rough handling are likely probable causes of the reported event.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 for future complaints and investigate as necessary.We consider this investigation closed.

• 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: 11797351
• MDR Text Key: 249695651
• Report Number: 1020279-2021-03902
• 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: 08/16/2021

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: 18JSM0785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1