MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR PMI RIGHT OCCIPITAL 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 09/14/2016

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 complaint was that the implant was brittle and cracked during plating.The complaint could not be verified as the implant was not returned.The implant dimensional analysis scan performed on the fc (first choice) and bu (back up) implants as part of the finished part inspection process were reviewed.The scans determined that both the fc and bu implants were manufactured according to design requirements provided by the customer and met all acceptance requirements.Based on the data available through the review and investigation of this file, the most likely underlying cause is surgeon technique.The ifu (instructions for use) states ¿using a powered instrument, an appropriately sized pilot hole must be placed at least 4 mm from the perimeter of the implant before inserting any screw.Irrigation while drilling is recommended.¿ there are no indications of manufacturing defects.Date received by mfr, if follow-up, what type?, and evaluation codes were updated based on the completion of the investigation.

• Brand Name: HTR PMI RIGHT OCCIPITAL 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: 6073091
• MDR Text Key: 58979902
• Report Number: 0001032347-2016-00637
• 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: 09/08/2019
• Device Model Number: N/A
• Device Catalogue Number: PM618478
• Device Lot Number: 705760
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2016
• 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