MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM 10.5" PECTUS SUPPORT BAR; PECTUS BAR

Model Number N/A

Device Problem Sharp Edges (4013)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00640.

Event Description

It was reported the surgeon compared the pectus bars and identified some have sharp/ pointy teeth.There was no patient involvement.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.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.The lot reported j3864168 was manufactured 8 sep 2016, while the surgeon provided part 01-3717 lot 084101 for reference, manufactured 23 may 2006.No lot number was provided for the 01-3716 bar.The print was reviewed for any engineering change request (ecrs); none were identified that affected 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.The material certification for part 01-3710-05 lot j3864168 was reviewed and no discrepancies were found.Device history record (dhr) review was unable to be performed for part 01-3716 as the lot number of the device involved in the event is unknown.The complaint cannot be verified and the most likely underlying cause cannot be determined.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: PECTUS SYSTEM 10.5" PECTUS SUPPORT BAR
• Type of Device: PECTUS BAR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7874625
• MDR Text Key: 120256090
• Report Number: 0001032347-2018-00639
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3710-05
• Device Lot Number: J3864168
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1