MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK XTRAFIX EXTERNAL FIXATION; PROSTHESIS, TRAUMA

Catalog Number UNK XTRAFIX EXTERNAL FIXATION

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported a 12 month pmcf single-centre, retrospective consecutive series study reported an anonymized patient group, from (b)(6), that looked at the safety, performance, and clinical benefits of the xtrafix large and small external fixation systems.The purpose of the study was the assessment of safety and performance, recorded by the ability of the device to stabilize the fracture of long bones during the course of treatment, until the device is exchanged by another device for definite fracture treatment.Case id (b)(6) underwent placement of a xtrafix device, at an unknown site.Subsequently, five days later, underwent a readjustment due to loss of position.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Event occurred in the (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report 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

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10.It was reported by a retrospective study, a patient underwent placement of a xtrafix device, at an unknown site on a right extremity.The patient was discharged home and subsequently, caught the device in a door frame and heard a crack.As the complaint indicates, the patient was instructed to maintain a non-weight bearing status and sustained external impact to the device, leading to the complication without allegation against the device prior to the event.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported a 12 month pmcf single-centre, retrospective consecutive series study reported an anonymized patient group, from united kingdom, that looked at the safety, performance, and clinical benefits of the xtrafix large and small external fixation systems.The purpose of the study was the assessment of safety and performance, recorded by the ability of the device to stabilize the fracture of long bones during the course of treatment, until the device is exchanged by another device for definite fracture treatment.Case id (b)(4) underwent placement of a xtrafix device, at an unknown site.Subsequently, five days later, underwent a readjustment due to loss of position.It was further reported that the patient underwent placement of a xtrafix device, at an unknown site on a right extremity.The patient was discharged home and subsequently, caught the device in a door frame and heard a crack.Upon follow-up, radiographs displayed loss of position; therefore, an adjustment was completed.Definitive fixation was implanted on day 19 and the event was considered resolved.As no additional information or product is available, we are unable to provide further information.

• Brand Name: UNK XTRAFIX EXTERNAL FIXATION
• Type of Device: PROSTHESIS, 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: 15174696
• MDR Text Key: 297347331
• Report Number: 0001822565-2022-02301
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XTRAFIX EXTERNAL FIXATION
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2023
• 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: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose