MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SHORT ANCHOR PLUG 10MM; PROSTHESIS, KNEE

Model Number	178552
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical product: cps xs sht spdl w pins 800lbf: catalog#178364, lot#204910; cps nut co-cr-mo alloy: catalog#178512, lot#906610; cps centering sleeve 13mm: catalog#178535, lot#665390.The 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.
Event or Problem Description
It was reported that during a right knee procedure, an anchor plug implant fractured during implantation.There was a surgical delay of forty minutes while the fractured component and the associated connections were removed and replacement devices were implanted.There was no patient impact reported as a result of this malfunction.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection of the returned item found it to exhibit signs of use and has fractured.Analysis of the fractured device sample showed that it fractured due to torsional overload.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CPS SHORT ANCHOR PLUG 10MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15191150
• Report Number: 0001825034-2022-01810
• Device Sequence Number: 5974766
• Product Code: KWA
• UDI-Device Identifier: 00880304461659
• UDI-Public: (01)00880304461659(17)311216(10)952730
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062998
• 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): 12/20/2022

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 Model Number: 178552
• Device Catalogue Number: 178552
• Device Lot Number: 952730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• 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: 07/17/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Male