MAUDE Adverse Event Report: ZIMMER BIOMET, INC. XTRAFIX EXTERNAL FIXATION SYSTEM

Catalog Number UNKNOWN

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported by a retrospective study that six days post implantation the patient underwent a readjustment due to loss of position.No additional information is available.

Manufacturer Narrative

(b)(4).Report source: foreign: united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, e1, g3, g7, h1, h2, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) 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

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

Event Description

It was further reported by a retrospective study, a patient underwent placement of a xtrafix device, at an unknown site of a right extremity.Subsequently, the patient left the hospital against medical advice and six days later presented to the minor injury unit with increasing pain and radiographic imaging displayed loss of position.The next day, the patient had an appointment at the fracture clinic and was admitted for a readjustment as the patient was too swollen for surgery.After the swelling resolved, the patient underwent definitive fixation on day 12.

Manufacturer Narrative

It was indicated that the patient left the hospital against medical advice.However, with the information provided it is unknown if this caused or contributed to the loss of position.As such, a definitive root cause cannot be determined.The reported event is unable to be confirmed.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

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

Manufacturer Narrative

(b)(4).Correction: supplemental medwatch (0001822565-2022-02339-2) was submitted with a notification date of december 4, 2023, in g3 and submitted on december 22, 2023; however, the correct notification date is april 19, 2023.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.

• Brand Name: XTRAFIX EXTERNAL FIXATION SYSTEM
• Type of Device: FIXATION SYSTEM
• 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: 15211115
• MDR Text Key: 297714044
• Report Number: 0001822565-2022-02339
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose