MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI K.S.2002-20191111 TOP RIGHT PARIETAL IMPLANT; CUSTOM MADE DEVICE

Model Number N/A

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The user facility is foreign; therefore a facility medwatch report will not be available.Report source ¿ (b)(6).

Event Description

It was reported that a custom cranial implant was larger than the defect.After an initial investigation, it was discovered the implant was designed using the wrong patient's scans.The issue was discovered the day before the planned surgery date.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 design vendor of this part confirmed the complaint that the implant was incorrectly designed.It was found that the uploaded dicom folder did not contain any part of the patient name that was indicated on the design input form.Searching for the patient name included in this dicom folder led the investigation to case pm622795.Case pm622795 was created on signature ftp on the same date as case pm622790.This upload error of the dicom folder thereby led to the processing of case pm622790 with the images of case pm622795.The error could not be identified during the triage procedure, as the location of defect field of the design input form was not filled and all parameters passed as per work instructions.The design/e-manufacturing was reviewed, which confirmed the incorrect dicom files were uploaded to the folder for this case.The dhr for this product was reviewed; no non-conformances were found.However, the design vendor confirmed that the incorrect series of patient images were used in the creation of this component.For patient matched htr-pmi implants (pmxxxxxx) and the previous year (from the notification date) regarding fit issues with the implant, there is a complaint rate is 1.68%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is due to an operator error.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 K.S.2002-20191111 TOP RIGHT PARIETAL IMPLANT
• Type of Device: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9689588
• MDR Text Key: 191985550
• Report Number: 0001032347-2020-00099
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00841036278496
• UDI-Public: 00841036278496
• 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,u
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2023
• Device Model Number: N/A
• Device Catalogue Number: PM622790
• Device Lot Number: 957180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1