MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CALCIGEN-S 25 GRAM PASTE; FILLER, BONE/BIOLOGICS

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual inspection of the returned product noted the following: the product was returned with the foil lid already torn off and the packaging is open.There is some liquid that is on the bottles and packaging.Inspection of the seal noted the cap was crimped and felt like it was intact when pulled off.The photos of the rubber seal marked rubber seal do not show any signs of liquid leaking out from around the rubber or the crimped part around it.The bottle was tipped upside down for several seconds to see again if anything would leak out.No liquid came out of the seal.The crimped portion of the seal was twisted in both directions to see if it was loose and it was not.None of the contents appear to be broken and no leaking was noticed from the bottle containing liquid.The source of the foreign liquid on the components is unknown.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.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
It was reported that during a procedure when the package was opened it was noticed that there was debris in the sterile packaging.Subsequently, another kit had to be open.

• Brand Name: CALCIGEN-S 25 GRAM PASTE
• Common Device Name: FILLER, BONE/BIOLOGICS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12697036
• Report Number: 0001825034-2021-02922
• Device Sequence Number: 4703196
• Product Code: MQV
• UDI-Device Identifier: 00887868284854
• UDI-Public: (01)00887868284854(17)221120(10)07590
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K013790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: 11/20/2022
• Device Model Number: N/A
• Device Catalogue Number: 348014
• Device Lot Number: 007590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1