MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.0MM X 10MM CTX SCR T6 S-T; PLATE, FIXATION, BONE

Model Number	72402010N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a trauma surgery, the head of an evos screw broke off, while inside the patient.An s&n backup was available.Surgery was not delayed.The patient outcome is unknown.
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 reported breakage could not be determined.The evos screws are implantable so biocompatibility is not an issue.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort, cannot be determined for the retained broken pieces.No further medical assessment can be rendered at this time.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.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.Additional information: d3 and g1.

• Brand Name: EVOS 2.0MM X 10MM CTX SCR T6 S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10513956
• Report Number: 1020279-2020-04504
• Device Sequence Number: 3656118
• Product Code: HRS
• UDI-Device Identifier: 00885556442197
• UDI-Public: 00885556442197
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/31/2021

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: 72402010N
• Device Catalogue Number: 72402010N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 07/31/2021
• 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