MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7/3.5 L-D FIBULA PL 11H L 147MM; PLATE, FIXATION, BONE

Model Number	72465111N
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ankle orif surgery, when taking the final x-ray pictures of the fracture, it was noted that a 2.7mm locking screw that was engaged into the evos lateral distal fibula plate, was found to be too long and invading the joint.It was decided to exchange the screw to a shorter one.When using the t8 driver to remove the screws, it stripped and screws were no possible to be removed.A high speed burr was used to remove the surrounding plate around the stripped screw head in order to have access to place a pair of multi grips over the screw head and then it was removed.A delay greater than 30 minutes occurred due to this event.No injuries to patient ere reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.(b)(4).

• Brand Name: EVOS 2.7/3.5 L-D FIBULA PL 11H L 147MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11449952
• Report Number: 1020279-2021-01935
• Device Sequence Number: 19787814
• Product Code: HRS
• UDI-Device Identifier: 00885556643341
• UDI-Public: 00885556643341
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 72465111N
• Device Catalogue Number: 72465111N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention