MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL - YELLOW 9.3 MM DIAMETER 38 CM LENGTH; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	47-2495-380-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
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.Report source: foreign: germany.Concomitant medical product: unknown zimmer natural nail screw: catalog#ni, lot#ni, qty#(b)(4).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.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported via a clinical study that a patient underwent a bone fixation procedure.On an unknown time frame post-implantation, the patient experienced pseudoarthrosis.Subsequently, the patient underwent revision surgery of the tibial nail with over-drilling and re-osteosynthesis.Due diligence is in progress for this event; to date no additional information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: 5.0 mm cortical screw fixed angle 3.5 mm: catalog#47248403550, lot#64064792, qty#(b)(4).5.0 mm cortical screw fixed angle 3.5 mm: catalog#47248405050, lot#63972019.5.0 mm cortical screw fixed angle 3.5 mm: catalog#47248404550, lot#63993576.5.0 mm cortical screw fixed angle 3.5 mm: catalog#47248404750, lot#64017064.5.0 mm cortical screw fixed angle 3.5 mm: catalog#47248403750, lot#64042650.5.0 mm cortical screw fixed angle 3.5 mm: catalog#47248403250, lot#63948174.The investigation is in progress.Upon 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 a left tibia bone fixation procedure.On an unknown time frame post-implantation, the patient experienced pseudoarthrosis.Subsequently, the patient underwent revision surgery of the tibial nail with overdriling and re-osteosynthesis.Due diligence is complete as multiple attempts have been made however it was reported that no further information or product is available.
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: mechanical (g04) - im nail.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.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.

• Brand Name: TIBIAL NAIL - YELLOW 9.3 MM DIAMETER 38 CM LENGTH
• 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: 15579353
• Report Number: 0001822565-2022-02912
• Device Sequence Number: 6498878
• Product Code: HSB
• UDI-Device Identifier: 00889024097704
• UDI-Public: (01)00889024097704(17)280331(10)63942063
• 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,Followup
• Report Date (Section B): 02/10/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 47-2495-380-09
• Device Catalogue Number: 47249538009
• Device Lot Number: 63942063
• 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: 09/27/2022
• Supplement Date Received by Manufacturer: 10/10/2022; 02/07/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 10/25/2022; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• 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.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male