MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM MEDIAL DISTAL TIBIA PLATE 10 HOLES/197MM-RIGHT; PLATE, FIXATION, BONE

Model Number	224.510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Malunion of Bone (4529); Physical Asymmetry (4573)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a2: patient¿s year of birth is 1968.B3: only the event year is known.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
An adverse event was reported for study subject (b)(6) as follows: the patient sustained a high energy trauma injury on (b)(6) 2023 resulting in an open tibial shaft fracture.A distal tibia plate was implanted on (b)(6) 2023.Four proximal screws and three distal screws were used for fixation.On (b)(6) 2023, nonunion, malunion, and malalignment of the right tibia was noted.Implant removal was performed on (b)(6) 2023.Recovery is in progress.This report involves one 4.5mm medial distal tibia plate 10 holes/197mm-right.This is report 8 of 8 for (b)(4).

• Brand Name: 4.5MM MEDIAL DISTAL TIBIA PLATE 10 HOLES/197MM-RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17224838
• Report Number: 8030965-2023-08186
• Device Sequence Number: 7097543
• Product Code: HRS
• UDI-Device Identifier: 10886982158314
• UDI-Public: (01)10886982158314
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K001945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 224.510
• Device Catalogue Number: 224.510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: Black Or African American