MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL YELLOW 10MM DIAMETER 32CM LENGTH; ROD, FIXATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Impaired Healing (2378); Malunion of Bone (4529)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient experienced pseudoarthrosis on unknown date.Patient was treated with osteosynthesis using additive anteromedial plate for delayed fracture healing of the tibial shaft.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 Description

Patient of a retrospective study had a pseudoarthrosis ending in osteosynthesis using additive anteromedial plate for delayed fracture healing of the tibial shaft approximately 9 months post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.D10: 47248405250 62974292 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.47248403550 63282441 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.47248403550 63222811 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.47248402750 63133283 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.47248403050 63269294 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.47248402750 63189667 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.Reported event was unable to be confirmed due to limited information received from the customer.Medical records were provided and reviewed by a health care professional.Review of the available records identified intial surgery with a zimmer natural nail system tibial nail.Insertion, a bending wedge repeatedly dislocates ventrally; after several attempts, it was threaded on with a nail.Revision op notes were not provided.The device history record (dhr) was reviewed and no discrepancies relevant 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 10MM DIAMETER 32CM LENGTH
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12446565
• MDR Text Key: 270528351
• Report Number: 0001822565-2021-02564
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47249532010
• Device Lot Number: 63102159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 90 KG