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

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: the event date reported is prior to the manufacture date.(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during the second surgery the cranioplasty implant was too flat, therefore the surgeon minimized the thickness from the inner side.Since the first implant had a high curvature the surgeon requested a flatter design for the second implant.The htr was implanted, however it is very thin and has a lot of predrilled suture holes.There was a delay of thirty (30) minutes.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.The surgeon requested that the implant be made more flat than his previously received implants.The design was reviewed with the surgeon and then approved by the surgeon prior to manufacturing.The manufacturing implant dimensional analysis scans were reviewed for both the first choice and the back up implant.The review of the dimensional analysis files found that both implants were made within specifications and design requirements approved by the surgeon.Device history record (dhr) was reviewed and no discrepancies were found.Based on the review of the dhr, surgeon approval form, and the dimensional analysis scans the complaint is not confirmed.Investigation results concluded that the reported event was due to surgeon preference.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.

• Type of Device: HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7753723
• MDR Text Key: 116245849
• Report Number: 0001032347-2018-00506
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• PMA/PMN Number: PK924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2021
• Device Model Number: N/A
• Device Catalogue Number: PM620093-D
• Device Lot Number: 810210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR