MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL - YELLOW 9.3 MM DIAMETER 34 CM LENGTH; ROD, FIXATION

Catalog Number	47249534009
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	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A2: year of birth: 1989.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.G2: foreign: germany.Multiple mdr reports have been filed for this event, please see associated reports: 0001822565-2023-01928, 0001822565-2023-01929 and 0001822565-2023-01930.The product will not be returned to zimmer biomet for evaluation as the product remains implanted.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 initial tibial bone fixation procedure.Subsequently, ten (10) months post-implantation, it was revealed that the fracture showed delayed union.The patient underwent spongiosa plastic surgery with plate fixation and removal of the secondary proximal screw.The outcome is pending as the patient may still need a full revision of the tibial nail due to the non-union.Due diligence is in progress for this event; to date no further information has been reported.
Event or Problem Description
It was reported that a patient underwent an initial right tibial bone fixation procedure.Subsequently, five (5) months post-implantation, it was revealed that the fracture showed delayed union.The patient underwent spongiosa plastic surgery with plate fixation of the cancellous bone and removal of the secondary proximal screw.The current outcome of the patient is pending.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; b7; d10; g3; h2; h6; h10.The following sections have been corrected: b3.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 mesh: catalog#ni, lot#ni; unknown tibial screw: catalog#ni, lot#ni; unknown femoral nail: 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
It was reported that a patient underwent an initial right tibial bone fixation procedure following involvement in a motor vehicle accident.Subsequently, five (5) months post-implantation, it was revealed that the fracture showed delayed union.The patient underwent an additional open reduction and internal fixation procedure with additional plate and screws applied to assist with fracture fixation and bone healing.Cancellous bone harvested from the patient¿s iliac crest was also applied to pseudoarthrosis in the center of the tibia.The surgeon has since stated that there is no chance of recovery or union due to the extent of the injuries, and no revision is currently planned until further review of the patient¿s healing progress at the one year follow up.
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#: 65007557; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#: 47248404750, lot#: 65028053; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#: 47248405550, lot#: 65023613; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#: 47248403250, lot#: 65225671; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#: 47248404250, lot#: 65007909; 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head: catalog#: 47248403550, lot#: 65225643; unknown mesh: 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.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/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three months post-implantation x-rays were normal, rom improved, and reported inability to bear full weight.Severe pain persisted for which medication was taken.Five months post-implantation it was reported there was no sign of infection, inability to bear full weight and pain were still present.A second proximal screw was removed and a plate was added to fixate the spongiosa.Further, bone was harvested from the iliac crest and placed in the center of the tibia, and a drain was placed.Review of the provided x-rays found that overall fit and alignment of the implants is anatomic.Bone quality is mildly osteopenic on all images.No loosening of hardware is identified.Fracture alignment is improved following both operative procedures.On the final images, there appears to be early incorporation of bone graft and partial but incomplete fracture healing.This complaint is confirmed by provided medical records.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 34 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: 17338460
• Report Number: 0001822565-2023-01927
• Device Sequence Number: 6477806
• Product Code: HSB
• UDI-Device Identifier: 00889024097568
• UDI-Public: (01)00889024097568(17)301206(10)64929684
• 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
• 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,Followup
• Report Date (Section B): 11/09/2023

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: 47249534009
• Device Lot Number: 64929684
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 08/04/2023; 11/08/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/08/2023; 08/28/2023; 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 96 KG