MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 4.7MM X 55MM OST SCR F-T; PLATE, FIXATION, BONE

Model Number	72424755
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported, that a evos 4.7mm x 55mm ost scr f-t broke during implantation.The screw remained inside the patient.Surgery was completed, without delay, by using the same device.Patient's current status is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.The images provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, per subsequent e-mail, no clinical information will be provided.However, without adequate documentation to fully evaluate this complaint the root cause of the reported breakage could not be determined.Although, we cannot rule out a procedural variance as a contributing factor.According to the report, although the screw was broken, the screw remained inside the patient.It is unknown if the ifu the evos 4.7mm x 55mm ost scr f-t 81104182 rev e, was adhered to.The ifu warns: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ based on the information provided, the surgery was completed, without delay, by using the same device.The evos screw is implantable, since the broken screw was still able to provide fixation, micro-motion and or migration is unlikely.The impact to the patient beyond that which has been reported could not be determined based on the limited information provided.Therefore, no further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.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.Some potential causes for this event could include but are not limited to, excessive forces applied to implant or 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 4.7MM X 55MM OST SCR F-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12502452
• Report Number: 1020279-2021-07029
• Device Sequence Number: 20120267
• Product Code: HRS
• UDI-Device Identifier: 00885556637531
• UDI-Public: 00885556637531
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K172262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 72424755
• Device Catalogue Number: 72424755
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/14/2021
• 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