MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB 14MM RAPIDFLAP CLAMP

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 01/30/2016

Event Type  Injury  

Manufacturer Narrative

The device evaluation is anticipated, a follow up report will be sent upon completion of the product evaluation.

Event Description

The sales associate reported a revision.The rapidflap ls clamp was implanted on (b)(6) 2016.Post-operative ct scan after the operation indicated no event.On (b)(6) 2016, ct scan indicated that the outer plate detached and revision surgery was performed.The outer plate was removed.The post and inner plate have remained in the patient.The outer plate was the only part removed from the patient.

Manufacturer Narrative

Per the device evaluation, the following were updated: contact office, phone number, date received by mfr, if follow up, what type?, device evaluated by mfr?, evaluation codes.The warnings in the package insert state this type of event can occur.The broken device was returned for evaluation.According to the evaluation, the complaint that the outer plate of the lactosorb rapid flap clamp detached in situ was confirmed.The most likely underlying cause was determined to be the surgeon did not follow the instructions for use (ifu).According to the evaluation, there are two instructions that were not followed for the possible underlying cause: the first possible underlying cause is due to the surgeon only using 2 lactosorb rapid flap clamps instead of 3 lactosorb rapid flap clamps as stated in the ifu.The ifu states, ¿before replacing the bone flap, position a minimum of three (3) lactosorb rapidflap ls clamps around the craniotomy line in order to achieve optimum stability.Note: the clamps should be placed equidistant from each other around the flap.Therefore, if using three clamps, they should be positioned 120º apart.If using four clamps, they should be positioned 90º apart.¿ the second possible underlying cause is due to not enough post being melted onto the outer plate.The ifu states, ¿flatten the approximate 2mm of post remaining above the upper disc using the contouring tip of the lactosorb heat/contouring pen.Do not heat this device by any other means.¿ there are no indications of a manufacturing defect.

• Brand Name: LACTOSORB 14MM RAPIDFLAP CLAMP
• Type of Device: 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: 5503667
• MDR Text Key: 40408032
• Report Number: 0001032347-2016-00131
• 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: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 915-0020
• Device Lot Number: 211270
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention