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

Catalog Number	71802608
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8609890
• Report Number: 1020279-2019-01916
• Device Sequence Number: 19349276
• Product Code: HRS
• UDI-Device Identifier: 03596010585028
• UDI-Public: 03596010585028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2022
• Device Catalogue Number: 71802608
• Device Lot Number: 17HM13310
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1