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

Catalog Number	47249538009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip surgery on and unknown date.Subsequently, it has been recommended that the patient undergo a revision surgery due a delay in the healing of the patient's bone.Attempts have been made to obtain additional information, but no additional information has been obtained at this time.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 47259538009, bg-znn tib nail 9.3mmx38cm unv; lot#: unknown.G2: foreign: france.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b3; b4; b5; d2; d4; d6; g2; g3; g6; h1; h2; h4.The following sections were corrected: e1; e3.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip arthroplasty eight (8) months ago.Subsequently, the patient was revised approximately three (3) and a half months ago to explant the screw due to dynamization.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6.Intramedullary nail systems are designed to provide stable internal fixation for various long bone fractures and have been designed for specific applications to help restore the shape of the fractured bone to its natural, pre-injured state.Long bone fractures follow specific regenerative patterns, creating a complex biological healing process and placing a patient at a heightened risk of delayed union.The healing of bone can be complicated by patient comorbidities such as diabetes, obesity, smoking, level of activity and other conditions that are known to slow a person¿s ability to heal.Delayed union can be treated through a secondary option called dynamization that involves removal of proximal or distal locking screws causing compression at the fracture site and promoting union.Dynamization with an intramedullary nailing system is considered a standard secondary treatment for facilitating second-stage healing.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TIBIAL NAIL 9.3 MM DIAMETER 38 CM LENGTH
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES/TRAUMA
• 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: 19393359
• Report Number: 0001822565-2024-01737
• Device Sequence Number: 20783540
• Product Code: HSB
• UDI-Device Identifier: 00889024097704
• UDI-Public: (01)00889024097704(17)310118(10)64922456
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2024

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: 47249538009
• Device Lot Number: 64922456
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 05/29/2024; 09/25/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/24/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2021
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male