MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR PMI MA 1967-20191022 RIGHT FRONTAL TEMPORAL PARIETAL IMPLANT; CUSTOM DEVICE

Model Number N/A

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

Patient Problem No Information (3190)

Event Date 12/12/2019

Event Type  Injury  

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.It is unknown at this time if the device will be returned for evaluation; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a 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 an incorrectly designed custom cranioplasty implant was discovered during surgery.The defect on the skull was on the left side and the implant was produced for the right side.Initial reports indicate that the incorrect scans were used in the design process.The surgery was completed using cement which resulted an unspecified delay.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.When investigating the received scan images for case (b)(4), it was determined that the incorrect series was used to create the implant.The scanned image series associated to case (b)(4) were instead erroneously used to create the case for (b)(4), and the issue could not be identified during the electronic manufacturing process given that the image series had the same scan date as indicated on the design input form.Furthermore, the location of defect field of the design input form was not filled, thus also preventing the operator error from initially being identified.The design/e-manufacturing was reviewed, which confirmed the incorrect image series was used to create the implant for this case and therefore the subsequent implant was not designed for the appropriate patient.The design vendor of this part confirmed the complaint that the implant was incorrectly designed.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, (b)(4).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 MA 1967-20191022 RIGHT FRONTAL TEMPORAL PARIETAL IMPLANT
• Type of Device: CUSTOM DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9569693
• MDR Text Key: 174482491
• Report Number: 0001032347-2020-00039
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: N/A
• Device Catalogue Number: PM622638
• Device Lot Number: 945690
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR