MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC MIIG X3 HV; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	84SSIN15
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device inspection revealed the following: visual examination confirms the vial is empty.Based on investigation, the root cause was attributed to a manufacturing related issue.The ifu clearly instructs the user that: "inspect devices prior to use for damage during shipment or storage or any out- of box defects." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A corrective action was executed to address this issue.The process for vial crimping was validated for use in production.Also, an aging study is in process to confirm the established shelf-life for the crimp top vial, rubber stopper, and crimp cap.While the new crimp-top vial has reduced the leakage complaints tremendously, there is an occasional occurrence of leakage due to initial improper fill or due to the crimp top becoming compromised.This lot appears to have been manufactured with the previous screw top as a vial cap and prior to the changes to the new cap.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the hospital found that there was no liquid in the liquid bottle after opening the sterile package during the operation, and the inner and outer packages were intact before opening.Finally, the operation was replaced by allogeneic bone from other manufacturers.There was a one hour delay.

• Brand Name: MIIG X3 HV
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 13120251
• Report Number: 3010667733-2021-00030
• Device Sequence Number: 11928338
• Product Code: MQV
• UDI-Device Identifier: 00840420134370
• UDI-Public: 00840420134370
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K024336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2023
• Device Model Number: 84SSIN15
• Device Catalogue Number: 84SSIN15
• Device Lot Number: 1554034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2015
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown