MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ RESORBABLE DISTRACTOR SYSTEM; LACTOSORB SCREW 2.0 X 7 MM 2.0 SYSTEM 2 PACK

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 08/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of the device history records show that the lot was released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The contraindications in the ifu (instructions for use) states "patients with limited blood supply insufficient quantity or quality of bone, or latent infection." the user facility is foreign; therefore a facility medwatch report will not be available.The product was not returned by the hospital for an evaluation.Without a product return, no product evaluation is able to be conducted.It is stated that the surgeon did not blame the lactosorb screws but the bone quality of the patient.Based on this statement the cause of the complaint is determined to be patient condition.If additional information is obtained that adds value to the relevant content of this report and/or a different conclusion can be drawn, a follow-up report will be sent.This is report one of four for the same event.Reports two through four are reported on mfr #0001032347-2017-00164 through 0001032347-2017-00166.

Event Description

On a post-market survey for lactosorb distraction system, it was reported that the 1.5 mm screws are not working with the anatomical size of the pediatric patients.In some cases, the surgeon ends up suturing the product to the patient.Additionally, if the bone quality is not good, the lactosorb screws won't hold up.Specifically, it was stated that the surgeon had problems securing the distraction plate with screws.The surgeon's comment was that the patient had poor bone quality and the screws would not hold.The distraction plates were secured with pds (non-zimmer biomet product) sutures.The event created a delay of thirty to forty-five minutes to the procedure.It was added that the surgeon did not blame the lactosorb screws but the bone quality of the patient.

• Brand Name: LORENZ RESORBABLE DISTRACTOR SYSTEM
• Type of Device: LACTOSORB SCREW 2.0 X 7 MM 2.0 SYSTEM 2 PACK
• 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: 6379978
• MDR Text Key: 69147346
• Report Number: 0001032347-2017-00163
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK002083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: N/A
• Device Catalogue Number: 915-2301
• Device Lot Number: 144150
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2016
• Is the Device Single Use?: Yes
• 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