MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB RAPIDFLAP; PLATE, BONE; LACTOSORB 14MM RAPIDFLAP CLAMP

Model Number N/A

Device Problem Device Inoperable (1663)

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

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.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.(b)(4).

Event Description

It was reported the surgeon understands that at least three lactosorb spin down (lssd) clamps should be placed around the craniotomy site.However, the surgeon removed arachnoidal cyst from the patient and used only two lssd clamps for the craniotomy since the craniotomy size was very small.The outer plate of the lssd (one of two lssds) was idling and the fixation power was lost.The procedure was completed using the new clamp and the surgical delay was less than ten minutes.

Manufacturer Narrative

The product identity was confirmed in the product evaluation.The returned parts were visually inspected and it was seen that the inner plate was returned with a small portion of the post stuck within the plate.The post has blood on it; therefore the inner plate cannot be handled.The outer plate was also returned and it was seen that the threaded hole has been melted and gouged.This damage seen on the plate likely occurred after the clamp was placed and the outer post was melted.Due to the damage on the outer plate and the majority of the post not being returned the complaint cannot be verified.The most likely underlying cause of this complaint cannot be determined as the outer plate was damaged during removal of the plate and the post was not returned.

• Brand Name: LACTOSORB RAPIDFLAP
• Type of Device: PLATE, BONE; LACTOSORB 14MM RAPIDFLAP CLAMP
• 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: 6543739
• MDR Text Key: 74399219
• Report Number: 0001032347-2017-00346
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK003281
• 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,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 915-0020
• Device Lot Number: 479790
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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): Required Intervention