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U.S. Department of Health and Human Services

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

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BIOMET MICROFIXATION LACTOSORB TRAUMA PLATING SYSTEM LACTOSORB 1.5MM 4 HOLE EXTENDED STRAIGHT PLATE Back to Search Results
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. Report one of two for the same event, reference 0001032347-2016-00734.
 
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 one of two for the same event. Report two of two is reported on mfr #0001032347-2016-00734-1.
 
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 one of two for the same event. Report two of two is reported on mfr #0001032347-2016-00734-2.
 
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Brand NameLACTOSORB TRAUMA PLATING SYSTEM
Type of DeviceLACTOSORB 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 Key6147451
MDR Text Key61537456
Report Number0001032347-2016-00733
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK955729
Number of Events Reported1
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 Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2019
Device Model NumberN/A
Device Catalogue Number915-2414
Device Lot Number251880
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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