MAUDE Adverse Event Report: BIOMET MICROFIXATION MAYO-HEGAR NEEDLE HOLDER STANDARD TC

Model Number N/A

Device Problem Fracture (1260)

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

Event Type  Injury  

Manufacturer Narrative

Ak is the date code etched on the product which identifies the item as being manufactured between january and june of 1995, however the lot number is unable to determined.A visual inspection revealed moderate signs of wear including minor scratches and spots of discoloration.A small piece of the knurled jaw was broken off.The most-likely cause for the complaint was determined to be excessive force.There are no indications of manufacturing defects.This report is late as it was part of a retrospective review based on enhancements made to our reporting policies.

Event Description

It was originally reported this instrument "doesn't latch anymore." the event occurred during surgery with no delay or harm to the patient.However the product evaluation identified the product was broken at the tip.See h10 narrative for the product evaluation details.

• Brand Name: MAYO-HEGAR NEEDLE HOLDER STANDARD TC
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6396979
• MDR Text Key: 69651648
• Report Number: 0001032347-2017-00145
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 51-6511
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention