MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL - YELLOW 9.3 MM DIAMETER 32 CM LENGTH; ROD, FIXATION

Model Number	47-2495-320-09
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Malunion of Bone (4529)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A2: year of birth (b)(6).D10: medical product: tibial nail cap 10 mm height: catalog#47248700510, lot#ni; 5.0 mm diameter cortical screw - red partially threaded 3.5 mm hex head: catalog#47248303050, lot#65167378; 5.0 mm diameter cortical screw - red partially threaded 3.5 mm hex head: catalog#47248304250, lot#65035192; 5.0 mm diameter cortical screw - red partially threaded 3.5 mm hex head: catalog#47248303250, lot#65167627; 5.0 mm diameter cortical screw - red partially threaded 3.5 mm hex head: catalog#47248303250, lot#65007866; unknown 5-793.3r variax stryker plate: catalog#ni, lot#ni.G2: foreign: germany multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-01612; 0001822565-2023-01613; 0001822565-2023-01614; 0001822565-2023-01615; 0001822565-2023-01616.Customer has indicated that the product will not be returned to zimmer biomet for evaluation as the product has been discarded.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
Event or Problem Description
It was reported via a clinical study that a patient underwent an open reduction of a two-stage fibula fracture and distal tibial fracture following a motorcycle accident.Subsequently, eight (8) months post-implantation, the patient began to have complaints while walking and underwent revision surgery due to malunion of the fracture.It was reported that the tibial nail was implanted in the incorrect position during the initial surgery, resulting in misalignment of the ankle.The tibial nail was revised and the outcome has been reported as resolved.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: tibial nail cap 10 mm height: catalog#: 47248700510, lot#: 65166398; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#: 47248403050, lot#: 65167378; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#: 47248404250, lot#: 65035192; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#: 47248403250, lot#: 65167627; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#: 47248403250, lot#: 65007866; unknown 5-793.3r variax stryker plate: catalog#: ni, lot#: ni.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code: im nail.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: dx: distal tibia fracture.Acquired limb deformity of ankle and foot, hindfoot valgus in the case of intramedullary nail osteosynthesis, ¿in the course of the procedure, however, a valgus malalignment was observed distally and the fracture was now fully developed, resulting in complaints when walking on the medial foot.Therefore, a varicose osteotomy was indicated.¿ laterally the fibula is cut and reduction performed.Variax plate (competitor) is placed laterally and fixed distally with four screws and proximally with two screws.Anatomical pilon plate is applied to tibia, fixed distally with four screws and proximally with five screws.Anatomical reduction and good position achieved of reconstructed joint, osteosynthesis procedure: by plate, removal of an intramedullary nail from the tibial shaft, varicose osteotomy distal tibia, closed wedge osteotomy (conversion by 10°, medial pos).Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: oblique orientation of the distal syndesmotic screw with lucency surrounding the screw which could indicate loosening or could be iatrogenic from placement.Interval revision, as above.The reported event is confirmed from the provided x-rays.The root cause of the reported issue is attributed to the user placing the nail incorrectly.The reporter admits this and the x-rays show the nail's oblique placement.Investigation results concluded that the reported event is attributed to the user placing the nail incorrectly.As the surgeon acknowledged the incorrect placement, a report of the investigation findings will not be sent detailing the proper placement.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: TIBIAL NAIL - YELLOW 9.3 MM DIAMETER 32 CM LENGTH
• Common Device Name: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17134549
• Report Number: 0001822565-2023-01611
• Device Sequence Number: 6523622
• Product Code: HSB
• UDI-Device Identifier: 00889024097490
• UDI-Public: (01)00889024097490(17)310417(10)65060870
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2023

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: 47-2495-320-09
• Device Catalogue Number: 47249532009
• Device Lot Number: 65060870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 10/23/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/17/2023; 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 65 KG