MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI TOMOFIX MEDIAL HIGH TIBIA PLATE-4 HOLES/SMALL; PLATE, FIXATION, BONE

Model Number	440.831
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on an unknown date, the patient underwent a revision procedure of a tomofix opening wedge nail tibial osteotomy due to non-union.Originally, the patient was implanted with a tomofix osteotomy system on (b)(6) 2019.The tomofix plate, five (5) locking head screws and one (1) cortex screw were explanted and a new plate and screws were put in with the same plate and screws.It is unknown if there was a surgical delay during revision.Patient and procedure outcome was unknown.This complaint involves seven (7) devices.This is 1 of 7 for report (b)(4).

• Brand Name: TI TOMOFIX MEDIAL HIGH TIBIA PLATE-4 HOLES/SMALL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9241081
• Report Number: 2939274-2019-61700
• Device Sequence Number: 19223692
• Product Code: HRS
• UDI-Device Identifier: 10886982220677
• UDI-Public: (01)10886982220677
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: 440.831
• Device Catalogue Number: 440.831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR