MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM L-P TIBIA PL 13H L 167MM; PLATE, FIXATION, BONE

Model Number	72463113
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery in an attempt to lock a 55 mm, 3.5 locking screw into a va hole in the (72463113) 13 hole left 3.5 lateral proximal tibia plate, the screw popped right through the va hole.It was opted to finished the screw on power through a medial exit hole in the patient.A larger headed screw was used to replace the locking screw.No delay reported.
Additional Manufacturer Narrative
The associated device, used in treatment, was not returned, thus visual inspection could not be performed.A review of the device history records could not be performed due to no device batch information being provided.There is no evidence to suggest the devices failed to meet specifications.A complaint history review found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.A relationship, if any, between the subject device and the reported event could not be determined.Some potential probable causes of the event could include over torqueing of the screw or screw angled during insertion.Please refer to the instructions for use for recommendations on proper use of the device to prevent future reoccurrence of the reported event.The medical investigation concluded that, without product return and evaluation, the root cause of the ¿popped thorough¿ screw cannot be concluded; however, the va locking holes are manufactured for one-time penetration only.The patient impact beyond the additional bone and tissue holes (due to the opted medial exit of the screw via power) could not be determined.No further medical assessment can be rendered at this time.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.No further actions are being taken at this time.

• Brand Name: EVOS 3.5MM L-P TIBIA PL 13H L 167MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9255854
• Report Number: 1020279-2019-03821
• Device Sequence Number: 11703011
• Product Code: HRS
• UDI-Device Identifier: 00885556640432
• UDI-Public: 00885556640432
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 72463113
• Device Catalogue Number: 72463113
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 01/21/2020
• 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: Hospitalization; Required Intervention