MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT; HARD TISSUE REPLACEMENT -PATIENT MATCHED IMPLANT

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

Udi# (b)(4).A photograph of the implant in a bag was provided, however the whole implant is not visible.Unable to determine the part numbers of the screws and plates used to fixate the implant in the photograph.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.Without a product return, no product evaluation is able to be conducted.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.

Event Description

The distributor reported the first choice cranioplasty implant crumbled during implantation.The back-up implant was used to complete the surgery.It is reported there was a longer delay, however the duration is unknown.Additional information was requested but has not been received at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: date of this report, describe event or problem, date received by manufacturer, type of report and follow-up number, follow-up type, additional narratives/data.

Event Description

It was reported the implant was not pre-drilled and broke while screws were being inserted.The surgical delay was twenty minutes.No foreign body remained in the patient.The product information for the plates and screws remains unknown at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The product was returned in a biohazardous condition so only a visual inspection could be performed.Visual inspection shows signs of an insertion attempt.Two plates and four screws were found fixated to the implant.There are no signs of htr material damage in the area of the implant where the screws remain inserted.Two small fragments of the implant have been fractured off of the implant on the superior and inferior edge towards the posterior side of the implant.The distributor reported that the surgeon did not pre-drill.This in combination with the close proximity of the insertion points to the edge of the implant most likely caused the implant to fracture.There are no indications of manufacturing defects.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Medical product: 1.5mm system 5 hole regular y plate catalog #: 01-7100 lot #: ni, 1.5mm system high torque (ht), sd, x-dr, screw catalog #: ni lot #: ni.Therapy date: (b)(6) 2017.Report source (check all that apply) foreign country: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00219 and 0001032347-2018-00220.

• Brand Name: HTR-PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT
• Type of Device: HARD TISSUE REPLACEMENT -PATIENT MATCHED 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: 7025203
• MDR Text Key: 91898476
• Report Number: 0001032347-2017-00797
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2020
• Device Model Number: N/A
• Device Catalogue Number: PM619803
• Device Lot Number: 777060
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• 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
• Patient Age: 29 YR