MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ PECTUS SUPPORT BAR STABILIZER; PECTUS STABILIZER

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It is reported the pectus stabilizer loosened from the pectus bar and a revision surgery will be performed to re-secure the pectus bar to the stabilizer.In the original surgery fiberwire was used to secure the pectus bar and stabilizer, however the surgical resident failed to perform the necessary loop to adequately secure the bar to the stabilizer.

Manufacturer Narrative

The warnings and precautions in the package insert state "the surgeon is to be thoroughly familiar with the implants and the surgical procedure prior to surgery.The correct selection and placement of the implant is important.Preoperative planning to determine the most appropriate size and final position of the implant is required.The surgeon should avoid sharp bends, reverse bends, or bending the device at a hole.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." the lot number is unknown; therefore, the device history records are unable to be reviewed.Device manufacture date is unknown.The pectus bar and stabilizer were re-secured, therefore, no products were explanted and no product evaluation can be performed.Based on the information provided the most likely cause of the event is due to improper stabilization.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Date of event and implant date are unknown.

• Brand Name: LORENZ PECTUS SUPPORT BAR STABILIZER
• Type of Device: PECTUS STABILIZER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 4915492
• MDR Text Key: 6030595
• Report Number: 0001032347-2015-00309
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK981789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01-3801
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/15/2015
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention