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

Model Number	47-2484-035-50
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a clinical study that a patient underwent a left tibial bone fixation procedure.Sixty-seven days post-implantation, the patient experienced osteosynthesis failure with recurvatum malposition.Subsequently, the patient underwent revision surgery to remove the malpositioned tibial nail and associated screws.Due diligence is complete as multiple attempts have been made; however no further information or product is available.
Additional Manufacturer Narrative
(b)(4).Event occurred in 2018 though exact date is unknown.Implantation and revision occurred in 2018 though exact date is unknown.Concomitant medical products: tibial nail - yellow 10 mm diameter 34 cm length: catalog#47249534010, lot#63984895 or lot#63456196.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#47248403050; lot#63841493 or lot#63972017.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#47248405050, lot#63773460.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#47248403050, lot#63893390.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#47248403250, lot#63985507 or lot#63799279.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#47248404250, lot#63791248.Foreign source: germany.Additional mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-02899; 0001822565-2022-03113; 0001822565-2022-03114; 0001822565-2022-03116; 0001822565-2022-03117.Customer has indicated that the product will not be returned to zimmer biomet for evaluation, as it was requested but not returned by the hospital.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, this device was determined to be not reportable.The adverse event of osteosynthesis failure can be attributed to the concomitant tibial nail and is not related to the cortical screws.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon reassessment of the reported event, this device was determined to be not reportable.The adverse event of osteosynthesis failure can be attributed to the concomitant tibial nail and is not related to the cortical screws.The initial report was forwarded in error and should be voided.

• Brand Name: 5.0 MM DIAMETER CORTICAL SCREW FIXED ANGLE 3.5 MM HEX HEAD
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 15715690
• Report Number: 0001822565-2022-03115
• Device Sequence Number: 14683319
• Product Code: HSB
• UDI-Device Identifier: 00889024094017
• UDI-Public: (01)00889024094017(17)280331(10)63979285
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 02/01/2023

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: 47-2484-035-50
• Device Catalogue Number: 47248403550
• Device Lot Number: 63979285
• 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: 10/10/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2018
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male