MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ NEEDLEHOLDER DEL MICRO TC; HOLDER, NEEDLE; ORTHOPEDIC

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 01/15/2017

Event Type  Injury  

Manufacturer Narrative

The user facility is foreign; therefore a facility medwatch report will not be available.Without a product return, no product evaluation is able to be conducted.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 is reported the needle holder broke during a "flap" procedure that took place on (b)(6) 2017.The device is said to have been inspected by the customer prior to clinical/ patient use.A part of the jaw of the needle holder fell into the patient and it was removed.There was no delay that exceeded thirty minutes.The procedure was completed using another needle holder.There was no injury to the patient and the patient is in stable condition.

Manufacturer Narrative

The device evaluation is in progress, a follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The product identity was confirmed in the product evaluation.Visual evaluation confirms that the needle holders are broken.One of the jaws has completely fractured off and was not returned with the product.The most likely cause of the complaint is determined to be excessive force on the needle holders when squeezing to grip a needle.Aesthetically, the instrument looks to be in good condition with minimal signs of wear.Instructions for use states: avoid undue stress or strain when handling or cleaning instruments.The non-conformance database was reviewed and there are no non-conformances.

• Brand Name: LORENZ NEEDLEHOLDER DEL MICRO 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: 6540439
• MDR Text Key: 74293069
• Report Number: 0001032347-2017-00337
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2017

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: 51-6598
• Device Lot Number: 428420
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: 06/30/2017; 07/27/2017
• Supplement Dates FDA Received: 07/14/2017; 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/1997
• 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