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

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 12/09/2016

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.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 during the procedure, the implant was soaked in an antibiotic solution before implantation.During insertion into the defect, a corner of the implant broke off, the plastic surgeon felt that this broke with unusually little force.He then tested the strength of the implant in his fingers and it broke in half.He then opened the back-up implant for use and together with the neuro surgeon they inspected it.He states that the edges broke off easily and crumbled in his hands, again he broke it in pieces very easily with little force required.The implant could not be used on the patient, and he completed the procedure using titanium mesh.

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.

Manufacturer Narrative

The product identity was confirmed in the evaluation.Both the first choice (fc) and backup (bu) implants were returned in biohazard condition but opened and reviewed in the cadaver lab.Both implants were fractured into multiple pieces.One was soaked in blood and is likely the first choice that fractured during insertion.This device is not designed to be load bearing (which was applied by the surgeon).This specific implant is relatively small and thin, making it more susceptible to excessive force.The implant dimensional analysis scan performed on the fc and bu 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.The complaint was confirmed as both the first choice and back up were returned in multiple pieces.This device is not intended to be load bearing.The most likely cause of the complaint was determined to be excessive force applied to the implant.

• Brand Name: HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
• Type of Device: HTR-PMI RIGHT SPHENOID TEMPORAL IMPLANT
• 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: 6224701
• MDR Text Key: 63951028
• Report Number: 0001032347-2017-00014
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: PK924935
• 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,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2019
• Device Model Number: N/A
• Device Catalogue Number: PM618619
• Device Lot Number: 719030
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2016
• 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): Other