MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7/3.5MM PL-D FIBULA PL 5H R 93MM; PLATE, FIXATION, BONE

Model Number	72465405
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Plate part no: 72465405 (not found on search by number or description).It was reported that during surgery the surgeon was unable to get locking screw heads to engage with tabs in hole of plate.It is unknown if there was a delay.There is no injury reported and a s&n back up device was available to finish the surgery.
Additional Manufacturer Narrative
Results of investigation: the associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device could not confirm the stated failure mode.Some of the screw holes are damaged from attempted use.The device was manufactured in 2019 and shows signs of use.A dimensional evaluation of the returned device could not confirm the stated failure mode.The device was found to be within specifications.A review of complaint history did not reveal similar events for the listed device.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A potential probable cause could be but is not limited to user error.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EVOS 2.7/3.5MM PL-D FIBULA PL 5H R 93MM
• 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: sarah freestone ; 1450 brooks rd.; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 10228603
• Report Number: 1020279-2020-02898
• Device Sequence Number: 19618705
• Product Code: HRS
• UDI-Device Identifier: 00885556648612
• UDI-Public: 00885556648612
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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 Model Number: 72465405
• Device Catalogue Number: 72465405
• Device Lot Number: 19AM06172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• 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