MAUDE Adverse Event Report: BIOMET MICROFIXATION MAYO-HEGAR NEEDLEHOLDERS, STANDARD INSERT; HOLDER, NEEDLE, ORTHOPEDIC

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the instrument fractured during a procedure.The fractured portion did not fall in the patient's mouth.The procedure was completed using another instrument.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The needle holder showed signs of use with some minor scratching and discoloration and also had a fracture at the base of one of the two tips.Manufacturing history was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force being applied during use, beyond what the instrument was designed to encounter.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: MAYO-HEGAR NEEDLEHOLDERS, STANDARD INSERT
• Type of Device: HOLDER, NEEDLE, ORTHOPEDIC
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8355828
• MDR Text Key: 136772183
• Report Number: 0001032347-2019-00129
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

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: 51-6511
• Device Lot Number: 060522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1