MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB TRAUMA PLATING SYSTEM LACTOSORB 1.5MM 4 HOLE EXTENDED STRAIGHT PLATE

Model Number N/A

Device Problem Device Inoperable (1663)

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

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

The user facility is foreign; therefore a facility medwatch report will not be available. Review of device history records show the lot released with no recorded anomaly or deviation. The warnings in the package insert state "exposure of lactosorb¿ to the bath should be a maximum of 15 seconds per bath with the temperature not exceeding 85 c. " 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. (b)(4). Report two of two for the same event, reference 0001032347-2016-00733.

Event Description

It was reported during an open reduction for a cheekbone fracture procedure two lactosorb plates were soaked for over 10 seconds in 80°c water, however the plates were unable to be bent. Titanium plates were used to complete the procedure. There was a surgical delay over 30 minutes, however the exact duration is unknown.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation. This is report two of two for the same event. Report one of two is reported on mfr #0001032347-2016-00733-1.

Manufacturer Narrative

The product identity has been confirmed in the evaluation. A visual inspection reveals the plates have no signs of use. The two plates were returned without the original packaging. There are no visual signs of a manufacturing defect on either plate. A water bath was heated up to 80 degrees c. Each plate was dipped in the water bath for approximately 10 seconds and then was bent. Once cooled the plate was then dipped back into the water bath for another 10 seconds and bent more aggressively. Testing found that each plate was easily bendable after the first 10 second dip in the water bath; therefore the complaint is not confirmed. After the second dip it was found that each plate could endure quite a bit of bending. The most-likely underlying cause for the complaint could not be determined as the products functioned as intended. This is report two of two for the same event. Report one of two is reported on mfr #0001032347-2016-00733-2.

• Brand Name: LACTOSORB TRAUMA PLATING SYSTEM
• Type of Device: LACTOSORB 1.5MM 4 HOLE EXTENDED STRAIGHT 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: 6147452
• MDR Text Key: 61538799
• Report Number: 0001032347-2016-00734
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/13/2020
• Device Model Number: N/A
• Device Catalogue Number: 915-2414
• Device Lot Number: 951410
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• 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 Treatment Data

Date Received: 12/06/2016 Patient Sequence Number: 1