MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR PMI A.F.M. RIGHT FRONTAL TEMPORAL PARIETAL IMPLANT; HARD TISSUE REPLACEMENT (HTR) - PATIENT MATCHED IMPLANT

Model Number N/A

Device Problem Fitting Problem (2183)

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

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the implant received was for the right side, but the patient's defect was on the left side of the cranium and the implant could not be implanted.The patient was already opened when this was discovered, and in the end, the doctor decided to put an acrylic.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.The complaint is confirmed.The complaint is that the implant was designed for the wrong side and could not fit.Design vendor and manufacturer of this part (cas) was notified of the fit problem and performed an investigation and provided their results.The following checks were performed:the design vendor discovered upon review of the diacom tags of the ct images indicated that the ct scans were taken with the patient in the feet first supine position.As a result of this, when the design was created in the software, it was designed on the right side and inverted.It also caused the design input form to reflect a right side implant, which was then approved incorrectly by the surgeon.The dhr of this product was reviewed and no non-conformance was found.There are no indications of manufacturing defects.For patient matched htr-pmi implants (pmxxxxxx) for the previous year (from the notification date) regarding fit issues leading to a major delay, there is a complaint rate of 0.81% which is no greater than the occurrence listed in the application fmea.The design vendor determined that the most likely underlying cause of this complaint is due to the scan operator did not set the patient position tag appropriately during ct image acquisition for case ¿pm621951¿ (images were tagged ¿ffs¿ instead of being tagged ¿hfs¿) and the defect location was misidentified in the dif, which was then approved incorrectly by the surgeon.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: HTR PMI A.F.M. RIGHT FRONTAL TEMPORAL PARIETAL IMPLANT
• Type of Device: HARD TISSUE REPLACEMENT (HTR) - PATIENT MATCHED IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8712849
• MDR Text Key: 148444866
• Report Number: 0001032347-2019-00329
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• PMA/PMN Number: K924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Model Number: N/A
• Device Catalogue Number: PM621951
• Device Lot Number: 901210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1