MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 4.7MM X 40MM OST SCR PT; PLATE, FIXATION, BONE

Model Number	72434740
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Bone Shedding Debris (4557)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an internal fixation, a evos 4.7mm x 40mm osteopenia screw partially threaded (case-(b)(4)) and a evos 4.7mm x 42mm osteopenia screw partially threaded (case-(b)(4)) were not suitable to fix all medial malleolus fractures and destroyed the smaller fragments of the bone.He states that the thread is difficult to start because it is not self tapping, and that he preferred the old sized 4.0mm cancellous screws from our previous orif set tc-100.Surgery was resumed, after a non-significant delay, with a back-up device.Current state of the patient 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, without the requested clinical information or the device, the root cause of the insertion difficulty cannot be determined.Per the surgeon, ¿the thread was difficult to start because it was not self-tapping, in addition, the surgeon preferred the old sized 4.0mm cancellous screws from our previous orif set tc-100.¿ subsequently, the surgery was resumed, after a non-significant delay, with a back-up device.However, the patient¿s status is unknown.Therefore, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint will be re-assessed.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.Some potential probable causes for this event could include but not limited to user error or procedural variance.Based on this investigation, the need for corrective action is not indicated.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 40MM OST SCR PT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12101214
• Report Number: 1020279-2021-05598
• Device Sequence Number: 3769330
• Product Code: HRS
• UDI-Device Identifier: 00885556637722
• UDI-Public: 00885556637722
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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: 72434740
• Device Catalogue Number: 72434740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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