MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL - YELLOW 11 MM DIAMETER 36 CM LENGTH; ROD, FIXATION

Catalog Number	47249536011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Ambulation or Postural Difficulties (2544)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).A2: year of birth: 1995 d10: medical product: tibial nail cap 10 mm height: catalog#47248700510, lot#ni; unknown zimmer natural nail dynamization proximal screw: catalog#ni, lot#ni; unknown zimmer natural nail transverse proximal screw: catalog#ni, lot#ni; unknown zimmer natural nail 25mm distal screw: catalog#ni, lot#ni; unknown zimmer natural nail 15mm distal screw: catalog#ni, lot#ni; unknown zimmer natural nail 5mm distal screw: catalog#ni, lot#ni g2: foreign: germany multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-01852; 0001822565-2023-01853; 0001822565-2023-01854; 0001822565-2023-01855; 0001822565-2023-01856; 0001822565-2023-01857.The product will not be returning to zimmer biomet for evaluation as the product remains implanted.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 an initial tibial bone fixation procedure.Subsequently, three (3) months post-implantation, it was revealed that the fracture showed delayed healing on diagnostic x-ray images.A surgical procedure is pending to address the delayed healing of the fracture.Due diligence is in progress for this event; to date no further information has been reported.
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.D10: medical product: tibial nail cap 10 mm height : catalog#47248700510, lot#65218914; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#47248403750, lot#65267134; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#47248404250, lot#65267145; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#47248403750, lot#65267126; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#47248405050, lot#65219144; unknown plate: catalog#ni, lot#ni.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.The product remains implanted.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified that initial visit diagnostics revealed fracture gap size >=1 cm, signs of infection, range of motion 0-130°, flexion deformity 20°.Two and a half (2.5) month follow-up showed no signs of infection, confirmed x-ray finding of adverse event, rom: 0-140°, able to bear full body weight, pain with deep palpitation and strong stress, oxford knee score 32, confirmed the patient continues to have moderate problems with ambulation and usual activities, delayed union of the tibia fracture and planning of dynamization of the nail (no date or operative records provided).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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.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 initial tibial bone fixation procedure.Subsequently, three (3) months post-implantation, it was revealed that the fracture showed delayed healing on diagnostic x-ray images.The patient was also experiencing pain, ambulation difficulties, and a decrease in daily "activities".A surgical procedure is pending to address the delayed healing of the fracture.

• Brand Name: TIBIAL NAIL - YELLOW 11 MM DIAMETER 36 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: 17275792
• Report Number: 0001822565-2023-01851
• Device Sequence Number: 5086237
• Product Code: HSB
• UDI-Device Identifier: 00889024097650
• UDI-Public: (01)00889024097650(17)311127(10)65316300
• 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: 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): 09/15/2023

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 Catalogue Number: 47249536011
• Device Lot Number: 65316300
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 09/08/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/08/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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: Other
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 70 KG