MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI SEXAUER RIGHT FRONTAL PARIETAL IMPLANT; CUSTOM MADE DEVICE

Model Number	N/A
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the incorrect implant was in the package.The issue was discovered when the surgery was in progress, therefore the patient was closed and admitted to the hospital until another implant could be made.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.Updated: a5, b4, b5, b7, g3, g6, h2.
Event or Problem Description
Patient brought to or for cranioplasty.Surgery started in usual manner, when it came time to insert the custom fabricated synthetic cranioplasty, packaging matched the patient's name, birth date and documentation for the planned preoperative 3d model, however the correct implant was not in the box.The surgeon aborted the procedure.Patient surgical wounds were closed and patient was admitted to the neuro unit for drain management and post-operative pain control.Once the correct device was received, the synthetic cranioplasty was performed and the device fit perfectly, with no gaps or excessive overhangs.Patient was discharged to home.Device has been retained in risk management office, but is not available for return to vendor.The sales rep is aware of this issue.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The htr-pmi sexauer rt frt par (item# pm624452, lot# 069370) was not returned for investigation.Photos were provided, which confirmed that the implant received did not match the patient's defect shown in the dhr.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a packaging issue.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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.There were no additional findings or changes to the investigation based on the information provided.The root cause remains the same; the cause is attributed to a packaging issue.

• Brand Name: HTR-PMI SEXAUER RIGHT FRONTAL PARIETAL IMPLANT
• Common Device Name: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: merrianne cassidy ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12690974
• Report Number: 0001032347-2021-00489
• Device Sequence Number: 1363668
• Product Code: KKY
• UDI-Device Identifier: 00888233047173
• UDI-Public: (01)00888233047173(17)240927(10)069370
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2024
• Device Model Number: N/A
• Device Catalogue Number: PM624452
• Device Lot Number: 069370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 11/01/2021; 03/21/2022; 09/26/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/23/2021; 03/25/2022; 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White