MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; ROD, FIXATION

Model Number	47-2483-042-50
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 1982.D10: medical product: tibial nail - yellow 9.3 mm diameter 32 cm length: catalog#47249532009, lot#ni; 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#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: 0001822565-2023-01611; 0001822565-2023-01612; 0001822565-2023-01613; 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.
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.The following sections have been updated: b4; b5; d1; d4; d10; e1; g3; h2; h10 d10: medical product: tibial nail - yellow 9.3 mm diameter 32 cm length: catalog#47249532009, lot#65060870; 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#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.Upon receipt of additional information, this device was determined to be not reportable.It was reported from the surgeon that the tibial nail was initially implanted in an incorrect placement which led to revision of the nail.The associated screws are not implicated in the incorrect placement and did not cause or contribute to the reported event.
Event or Problem Description
Upon receipt of additional information, this device was determined to be not reportable.It was reported from the surgeon that the tibial nail was initially implanted in an incorrect placement which led to revision of the nail.The associated screws are not implicated in the incorrect placement and did not cause or contribute to the reported event.

• Brand Name: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
• 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: 17134537
• Report Number: 0001822565-2023-01614
• Device Sequence Number: 12392951
• Product Code: HSB
• UDI-Device Identifier: 00889024094093
• UDI-Public: (01)00889024094093(17)310217(10)65035192
• 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): 11/01/2023

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: 47-2483-042-50
• Device Catalogue Number: 47248404250
• Device Lot Number: 65035192
• 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; 10/09/2023
• 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: 02/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 65 KG