MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS BAR BENDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot number: there are five possible lot numbers: 372900; 307010; 914170; 446890; 308560.Unique identifier (udi) number: (b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported "one of gripping-pin, used for pinching header portion, broke during the procedure.It happened when the surgeon was going to bend the pectus bar, because the necessity for the procedure." there was a delay between thirty minutes to one hour due to two issues, "the drop off of the bar from patient body by the breakage of bender instrument.As a result it had to re-autoclave urgently.Second was making certain alternative bender arrangement." the distributor reported the bender has been consigned over 200 times.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The pectus bar bender (part# 01-3905, serial# (b)(4) was returned without original packaging for evaluation.On visual inspection, the bender has one of the articulating rollers and pins (01-3905-04 and 01-3905-05) fractured from the rest of the instrument.Functional testing was not attempted due to the damaged nature in which the product was returned.The raw material certificate was reviewed and no discrepancies were found.There are no indications of manufacturing defects.Investigation results concluded that the reported event was due to the instrument experiencing force in excess of what it was designed to encounter.A summary of the investigation has been sent to the complainant.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 BAR BENDER
• Type of Device: BENDER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8045658
• MDR Text Key: 126363998
• Report Number: 0001032347-2018-00747
• Device Sequence Number: 1
• Product Code: HXW
• Combination Product (y/n): N
• PMA/PMN Number: K972420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• 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: 01-3905
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization