MAUDE Adverse Event Report: BIOMET MICROFIXATION BABY-CRILE-WOOD NEEDLE HOLDER FN 15CM TC; HOLDER, NEEDLE;ORTHOPEDIC

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported the instrument fractured while the surgeon was opening and closing the instrument.The fracture did not occur during use on a patient and the instrument was not over the surgical site.There was no impact to the patient or procedure as another instrument was available and used in the procedure.

Manufacturer Narrative

A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The instrument was visually evaluated and found to be fractured at the working end.The rest of the instrument is in good overall cosmetic condition with normal scratches and wear from use; no discoloration was observed.There were no indications of manufacturing defects.The inspection history was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force.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: BABY-CRILE-WOOD NEEDLE HOLDER FN 15CM TC
• Type of Device: HOLDER, NEEDLE;ORTHOPEDIC
• 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: 6802275
• MDR Text Key: 83036444
• Report Number: 0001032347-2017-00674
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2018

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: 51-6506
• Device Lot Number: 101413J13
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 08/14/2017; 01/30/2018
• Supplement Dates FDA Received: 09/13/2017; 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2013
• 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