MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. ACCUFILL BONE SUBSTITUTE MATERIAL; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number	307.034
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: item# 414.502; lot# 209517423.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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, the inner packaging of the scp cannula had a hole in it.Another device was used to successfully complete the procedure.No patient consequences were reported for the event.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that there is a hole on the right side of the packaging; however, the left side appears to have been torn when opened and not returned.The outer carton was not returned to rule out transit damage.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.It is confirmed that there is a hole and damaged to the pouch; however, the cause of the damage could not be determined.If any further information 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: ACCUFILL BONE SUBSTITUTE MATERIAL
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 56 e bell dr.; warsaw IN 46582
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 56 e. bell dr.; warsaw IN 46582
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19760298
• Report Number: 3008812173-2024-00002
• Device Sequence Number: 21118462
• Product Code: MQV
• UDI-Device Identifier: 00889024205123
• UDI-Public: (01)00889024205123(17)270204(10)50175
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K190814
• 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
• Report Date (Section B): 09/18/2024

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 Catalogue Number: 307.034
• Device Lot Number: 50175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2024
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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: NI
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female