MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.4MM X 22MM LCK SCR T7 S-T; PLATE, FIXATION, BONE

Model Number	72412422
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a trauma procedure, the head of the evos 2.4mm x 22mm locking screw t7 s-t did sit high when engaged into the plate.The implanted screw had to be removed and a different screw was used to completed the procedure.It is unknown if there was any surgical delay.The patient was not injured beyond the described event.
Event or Problem Description
It was reported that before procedure, was found that the head of the evos 2.4mm x 22mm locking screw t7 s-t did sit high when engaged into the plate.The screw was noticed to be longer than labeled on the package.The procedure was completed using a smith and nephew back up device, with no surgical delay.There was no patient affected.
Additional Manufacturer Narrative
H11: additional information received has identified that this event should be re-evaluated for mdr reporting.The malfunction was not find during a surgical case and, therefore, could not have caused or contributed to a serious injury.This event was then considered as a reportable malfunction.
Additional Manufacturer Narrative
Additional information was received that identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: EVOS 2.4MM X 22MM LCK SCR T7 S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10394365
• Report Number: 1020279-2020-03855
• Device Sequence Number: 19728156
• Product Code: HRS
• UDI-Device Identifier: 00885556430897
• UDI-Public: 00885556430897
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K140814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72412422
• Device Catalogue Number: 72412422
• Device Lot Number: 20DM02147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 01/07/2021; 07/28/2021
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 01/11/2021; 08/24/2021
• 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: Required Intervention