MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM M-D TIB LK PL8H R 160MM; PLATE, FIXATION, BONE

Model Number	71801108
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that it was noticed that the device had two labels indicating the reference number and the batch, but two separate expiry dates (00/09/2019 and 09/2024).The label 2024 is located under the film while, the label 2019 is stuck on top for re-labelling with gs1.It was not reported when the inconsistency was detected or if there was any patient involved.
Additional Manufacturer Narrative
Event description was updated according to new information received.
Event or Problem Description
It was reported that it was noticed that the device had two labels indicating the reference number and the batch, but two separate expiry dates (00/09/2019 and 09/2024).The label 2024 is located under the film while, the label 2019 is stuck on top for re-labelling with gs1.The inconsistency was detected before the procedure.No patient was involved.
Additional Manufacturer Narrative
The device was not returned for evaluation but the pictures were reviewed, and they confirm that the expiration date on the label on top of the film is different to the label under the film.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential causes for this event could include but not limited to incorrect system data at a facility not governed by smith + nephew.The contribution of the device to the reported event could be corroborated since the label on the package was different to the label on top of the film.This issue was evaluated through our internal quality process and determined to be isolated at this time.Based on this investigation, the need for corrective action is not indicated.Should the device or 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 M-D TIB LK PL8H R 160MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11159272
• Report Number: 1020279-2021-00316
• Device Sequence Number: 13605085
• Product Code: HRS
• UDI-Device Identifier: 03596010520661
• UDI-Public: 03596010520661
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2022

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: 09/24/2019
• Device Model Number: 71801108
• Device Catalogue Number: 71801108
• Device Lot Number: 14JM18210
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/21/2021; 03/24/2022
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 01/25/2021; 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown