MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT; HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT (PMI)

Model Number N/A

Device Problem Material Fragmentation (1261)

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

Event Date 09/16/2016

Event Type  Injury  

Manufacturer Narrative

Intraoperative fracture of the implant is a possible adverse effect listed in the package insert.No product will be returned to the manufacturer for evaluation as the first choice implant was discarded by the facility and the second choice implant remains implanted.Review of device history records show the lot released with no recorded anomaly or deviation.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).

Event Description

It was reported a pmma implant was too brittle and struggled to accept a screw.When the surgeon tried to plate the implant with 7mm screws the edges began to crumble and fall apart.The first choice implant and the broken pieces were removed and the back up implant was used to complete the craniotomy.This presented a delay of about fifteen to twenty minutes to the procedure.

Manufacturer Narrative

The product was not returned for evaluation.However, a root cause was identified during the evaluation of the complaint file.The product identity was confirmed in the review of device history records during the evaluation.According to the complaint evaluation, based on the data available through the review and investigation of the complaint file, the most-likely cause was determined to be surgeon technique.The ifu (instructions for use) states ¿using a powered instrument, an appropriately sized pilot hole must be placed at least 4mm from the perimeter of the implant before inserting any screw.Irrigation while drilling is recommended.¿ if this technique was not followed it could lead to the implant fracturing during plating.According to the evaluation, there are no indications of manufacturing defects.

Event Description

(in addition to what was already reported) more information about the surgical technique was received on jan 31, 2017.The sales associated reported he was present during the procedure and confirmed the placement of the screws was a minimum of 10 mm from the edge of the implant after the first choice implant cracked and crumbled to the point where it was not implantable.The sales associate advised that on both implants, the surgeon did not pre-drill.He reported that when the surgeon tried to insert the first screw into the backup implant with a manual driver the screw would only spin without gripping the cortical.The sales associate confirmed he believed the surgical technique was followed by the surgeon and reiterated the crumbling condition of the implant.

• Brand Name: HTR PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT
• Type of Device: HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT (PMI)
• 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: 6072988
• MDR Text Key: 59007132
• Report Number: 0001032347-2016-00634
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2019
• Device Model Number: N/A
• Device Catalogue Number: PM618377
• Device Lot Number: 702830
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2016
• 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