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

Model Number 71654501

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2020

Event Type  malfunction  

Event Description

It was reported that after the procedure, it was found that the underside of drop was chipped where blocking screw attachment goes in.There are not patient affected.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Results of investigation: the device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the anterior drop has several nicks, chipped pieces, burrs and deep gouges in the device.The device was manufactured in 2009 and it shows signs of significant wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.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: META ANTERIOR DROP
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10405294
• MDR Text Key: 202854694
• Report Number: 1020279-2020-03915
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010585820
• UDI-Public: 03596010585820
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71654501
• Device Catalogue Number: 71654501
• Device Lot Number: 09ESP0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1