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

Model Number	178552
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: cps sm sht spdl w pins 800lbf: catalog#178367, lot#439010; cps nut co-cr-mo alloy: catalog#178512, lot#136770.The device has been received by zimmer biomet and is under evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a total right knee procedure, an anchor plug implant fractured during implantation.There was a surgical delay of forty-five (45) 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.

• Brand Name: CPS SHORT ANCHOR PLUG 10MM
• Common Device Name: INSTRUMENT, 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: 16075215
• Report Number: 0001825034-2022-02871
• Device Sequence Number: 17699154
• Product Code: JDI
• UDI-Device Identifier: 00880304461659
• UDI-Public: (01)00880304461659(17)321020(10)148700
• 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
• Report Date (Section B): 12/29/2022

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: 148700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• 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: 12/08/2022
• Initial Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Female