MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE; PRSTHSIS,KN,PATLLO/FMROTIBL,SMI-CNSTRAIND,UNCMNTD,PRS,COATD,POLYMR/METAL/POLYMR

Catalog Number 71441144

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2018

Event Type  malfunction  

Event Description

It was reported that during surgery the align guide did not latch properly.Smith and nephew backup used.No delay to procedure, no injury to patient.Device will be returned.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device functioned as intended with a mating part and passed the gage check.The device exhibits signs of moderate wear/usage.A review of complaint history did not reveal additional complaints for the listed batch for 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that there was not a previous incident from the same or equivalent device that has caused a serious injury, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: GII MIS DCF ALIGN GDE
• Type of Device: PRSTHSIS,KN,PATLLO/FMROTIBL,SMI-CNSTRAIND,UNCMNTD,PRS,COATD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8061851
• MDR Text Key: 126971413
• Report Number: 1020279-2018-02428
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010497161
• UDI-Public: 03596010497161
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71441144
• Device Lot Number: 18AM04926
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1