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

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported by a retrospective study, that the patient underwent placement of a xtrafix device.Subsequently, five days later, underwent a readjustment due to loss of position.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 is 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: reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the part and 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

It was further reported by a retrospective study, a patient underwent placement of a xtrafix device, at an unknown site on a left extremity.Subsequently, the patient was non-compliant with weight bearing and elevation instructions; therefore, experienced loss of position.A readjustment was completed and remained hospitalized until a definitive fixation was completed on day 11.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The root cause of the reported issue is attributed to user error (patient non compliance), as it was noted the patient was non-compliant with weight bearing and elevation instructions.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.

• Brand Name: XTRAFIX EXTERNAL FIXATION SYSTEM
• Type of Device: APPLIANCE, 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: 15116070
• MDR Text Key: 296750086
• Report Number: 0001822565-2022-02212
• Device Sequence Number: 1
• Product Code: JDW
• 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,Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention