MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PRO-DENSE BONE GRAFT 4CC INTERNATIONAL; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	87SRIN04
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that when the inner package was opened, there was some liquid on the bottle, and the label was wet.This event caused the surgery to be delayed by two hours.
Additional Manufacturer Narrative
The complaint could be confirmed, since a video got received for evaluation and matches the alleged failure.Validation plan wd012868, biologics crimp cap vial 5, 10, 20cc vials was executed to address this issue.The process for vial crimping was validated for use in production.Also, wd012642 aging study is in process to confirm the established shelf-life for the crimp top vial, rubber stopper, and crimp cap.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.Visual inspection: visual examination of the two received products shows that the vials for liquid and powder are not returned for evaluation, furthermore the whole plastic inlay with the mixer instruments are also missing.On the other hand, the sealed bag with the tube and other parts got returned in an intact condition.Video examination: an inspection of the received video has shown that a sealed pouch got opened, the vial with the black screw top which was in the pouch had a wet label, and some liquide was running out of the pouch.Furthermore, it is visible that the lot number matches the one reported.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that when the inner package was opened, there was some liquid on the bottle, and the label was wet.This event caused the surgery to be delayed by two hours.

• Brand Name: PRO-DENSE BONE GRAFT 4CC INTERNATIONAL
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15532009
• Report Number: 3010667733-2022-00334
• Device Sequence Number: 14755490
• Product Code: MQV
• UDI-Device Identifier: 00840420140791
• UDI-Public: 00840420140791
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 03/12/2023
• Device Model Number: 87SRIN04
• Device Catalogue Number: 87SRIN04
• Device Lot Number: 1623454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2018
• 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