MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7MM X 24MM CTX SCR T8 S-T; PLATE, FIXATION, BONE

Model Number	72402724N
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: case (b)(4).
Event or Problem Description
It was reported that the evos screw broke while trying to remove it from the patient and a broken piece was retained in the patient.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the limited information provided, the root cause of the evos screw breakage or its removal cannot be determined.Additionally, no clinically relevant supporting documents were provided to support the implantation of the screw was not successful.The evos screw, it is made of a bio-composite material which is intended for implantation.However, the impact to the patient beyond the potential for screw migration and the potential risk for tissue inflammation and/or pain cannot be determined.It is unknown if there was a delay or if a backup device was available.Therefore, no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: EVOS 2.7MM X 24MM CTX SCR T8 S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10912261
• Report Number: 1020279-2020-06794
• Device Sequence Number: 19662535
• Product Code: HRS
• UDI-Device Identifier: 00885556450291
• UDI-Public: 00885556450291
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 08/20/2021

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: 72402724N
• Device Catalogue Number: 72402724N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 08/20/2021
• 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