MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS BAR BENDER

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical device: biomet microfixation pectus bar, catalog #: ni, lot #: ni.Therapy date: unknown.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported one of the bolts inside the hand held bender "popped out" and flew off the table while the surgeon was bending the bar in situ.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The pectus bar bender (part# 01-3905, lot# 534624) showed signs of wear.It has some minor scratching from general handling damage, the pin for the roller on the female bender arm had sheared off at the point where the roller interfaces with the bender arm, and the thumb press was out of position which held the elliptical roller in the elevated position.The pin experiences stress at this point when the handles are actuated to bend a bar.The thumb press was adjusted and the elliptical roller returned to its proper position.The manufacturing history was reviewed and no discrepancies were found.There are no indications of manufacturing defects.Investigation results concluded that the reported event was due to excessive force.The instructions for use (ifu) for this product states in the section titled warnings and precautions: avoid undue stress or strain when handling or cleaning instruments.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.

Event Description

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

• Brand Name: PECTUS BAR BENDER
• Type of Device: BENDER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7809281
• MDR Text Key: 118405929
• Report Number: 0001032347-2018-00565
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• 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: 01-3905
• Device Lot Number: 534624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1