MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS BLU PRBNT TI BAR 12IN; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 05/04/2022

Event Type  Injury  

Event Description

It was reported that patient underwent an initial procedure and subsequently after a fifteen days the bar was found to be flipped.A reoperation was performed and the surgeon was satisficed with the outcome.No additional information is available at this time.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: item# 78-8020, lot# unknown; pectus blu stabilizer ti.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00172.

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.Lot identification is necessary for review of device history records, lot identification was not provided for the stabilizers.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: both images demonstrate a pectus bar surrounding the inferior sternum.No change in positioning of the bar is seen on either of the views.The hardware appears intact.Otherwise unremarkable appearance of the chest.No confirmed abnormal findings on the provided images of the lateral chest including the pectus bar.The root cause of the reported issue is attributed to user error.Surgeon did not follow surgical technique: the surgeon utilized two synthes zipfix devices around the bar and around the ribs, instead of 0 pds ligatures secured through the hole in the bar on the patient¿s right (non-stabilizer) side.Synthes zipfix, is used for sternal closure, not pectus excavatum repair.Per surgical technique regarding the bar stabilization, it is recommended to select at least two separate ribs to secure the bar to prevent bar rotation.On the lateral ends of the bar, multiple 0 pds ligatures are secured through the hole in the bar and around the rib.The pds sutures should be placed under thoracoscopic guidance.The sutures should be secure but not so tight that they impinge on intercostal nerves.Per the ifu warnings, the implant can become dislodged, shift, or flip as a result of improper device selection, improper stabilization, not suturing the device(s), or patient activity too soon after surgery.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

Event Description

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

• Brand Name: PECTUS BLU PRBNT TI BAR 12IN
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; .; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14548552
• MDR Text Key: 292980915
• Report Number: 0001032347-2022-00171
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 78-6120
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2022
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 62 KG