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

Model Number N/A

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the "new" pectus support bars have "sharper teeth" this year.When the surgeon compares the new bars to the older bars, she notices ridges of the older bars are less sharp than those of the new bars.The surgeon advises that when she inserts the bars, they are "catching and tearing" on the pleural and intercostal muscle every time as well as the pre-pericardial sac some of the times.To prevent this, she makes an additional incision on the left side of the chest, inserts a camera, and uses forceps to grab the bar as it is inserted and guide the bar through to make sure it doesn't catch any tissue.This adds about ten minutes to her procedures.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Product identity could not be confirmed due to the product not being returned.Functional testing and inspections could not be performed due to the product not being returned and no x-rays, scans, or physician reports being provided.There was one photo provided in which there are two bars being held side by side for comparison.The part numbers are visible (left bar, part# 01-3707 and right bar, part# 01-3716), however the lot numbers are not visible.It appears that the radii of the teeth on the right bar are larger but this is difficult to determine without the product in hand.The print was reviewed for any engineering change requests (ecr), none were identified that impacted the radius of the teeth or bar edges.The available lots of pectus bars in stock were pulled for evaluation.None of the lots pulled exhibited sharp teeth.Device history record (dhr) review was unable to be performed as the part number and lot number of the device involved in the event are unknown.For these reasons, the complaint cannot be verified and the most likely underlying cause cannot be determined.There are no indications of manufacturing defects.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: LORENZ PECTUS SUPPORT BAR
• Type of Device: PECTUS BAR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7874610
• MDR Text Key: 120240739
• Report Number: 0001032347-2018-00637
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK972420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention