MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM LK RECON PL 8H 94MM; PLATE, FIXATION, BONE

Catalog Number 71802608

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the transparent wrapping was open while the outside package was good.Delay from more than an hour reported.Opened the second product in the case with the same failure mode which was resterilized and used and with it completed the surgery.No impact or injury to patient reported.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The outer sterile pouch was not sealed on one end.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.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: 3.5MM LK RECON PL 8H 94MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8609890
• MDR Text Key: 145086812
• Report Number: 1020279-2019-01916
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010585028
• UDI-Public: 03596010585028
• Combination Product (y/n): N
• PMA/PMN Number: K061352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2022
• Device Catalogue Number: 71802608
• Device Lot Number: 17HM13310
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1