MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 600 MM BAR; PIN, FIXATION, THREADED

Model Number 71062600

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that the 600 mm bar was found not sterile.It is unknown when this issue was discovered and if there was any delay or a back up was available if needed.No injuries to patient reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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 would be sterilized but appears to be unused and was returned without it's original packaging, the device was manufactured in 2018 and never been used.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.This device is a reusable instrument that can be exposed to numerous surgeries.Some potential probable causes for this event could include packaging damage or a user error, 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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 600 MM BAR
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11326701
• MDR Text Key: 231977897
• Report Number: 1020279-2021-01327
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 03596010486745
• UDI-Public: 03596010486745
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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: 71062600
• Device Catalogue Number: 71062600
• Device Lot Number: 18DM22279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1