MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB TRAUMA PLATING SYSTEM; 1.5MM 6 HOLE CURVED PLATE

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Staphylococcus Aureus (2058); No Code Available (3191)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

The package insert lists possible adverse effects: infection can lead to failure of the procedure.Neurovascular injuries can occur due to surgical trauma.Bending, fracture, loosening, rubbing, and migration of the devices can occur as a result of excessive activity, trauma or load bearing.Implantation of foreign materials can result in an inflammatory response or allergic reaction.Review of device history records show the lot released with no recorded anomaly or deviation.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.This is report one of two for the same event, reference report 0001032347-2017-00582.

Event Description

The patient had an infection in (b)(6) 2016 which cleared up after two months on antibiotics and steroids.The patient had infra-orbital margin surgery where the plate and screws were implanted on (b)(6) 2013.The patient complained of pain and it was identified the patient had an infection.The infection did not clear up with antibiotics and steroids, therefore a revision was performed (b)(6) 2017 to remove what appears to be fragments of the plate and/or screws that did not completely resorb.It is reported the patient is recovering.

Manufacturer Narrative

A follow up report will be sent upon completion of the device evaluation.This supplemental report one of two for the same event.Report two of two is reported on mfr #0001032347-2017-00582-1.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event could not be confirmed.The product identities could not be confirmed as only fragments were returned.The fragments returned were in a biohazardous condition and cannot be removed from their container.A visual inspection of the returned fragments was conducted and it cannot be determined the returned fragments are lactosorb products.Since the returned fragments are in a biohazardous condition a further investigation by removing the fragments cannot be completed.Lactosorb has a time to re-absorption of 12 months, as this complaint is 4 years after the initial implantation it is unlikely that the remaining product is lactosorb.Review of the complaint history determined that no further action is required as no were trends identified.Investigation results concluded that the reported event was due to the patient¿s condition.There are no indications of manufacturing defects.A summary of the investigation will be sent to the complainant.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.The following sections were updated: date of this report, date received by manufacturer, type of report and follow-up number, if follow-up, what type , device evaluated by manufacturer, additional narratives/data.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00582-2.

• Brand Name: LACTOSORB TRAUMA PLATING SYSTEM
• Type of Device: 1.5MM 6 HOLE CURVED PLATE
• 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: 6736716
• MDR Text Key: 80819743
• Report Number: 0001032347-2017-00581
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK955729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 915-2427
• Device Lot Number: 408050
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR