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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 178535 cps centering sleeve 13mm lot# 567750; mdr: 0001825034-2023-00076.Additional associated products: 178366 cps sm sht spdl w pins 600lbf lot# 567750; 178512 cps nut co-cr-mo alloy lot# 278090.
Event or Problem Description
It was reported the traction bar of compress anchor plug fractured while placing compression nut.Centering sleeve fracture noted as well.No known patient impact.
Event or Problem Description
It was reported the traction bar of compress anchor plug fractured while placing the compression nut.No pieces fell into the patient.No patient impact.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Additional associated products & mdrs.(void) 178535 cps centering sleeve 13mm lot# 567750.Mdr: 0001825034-2023-00076 (void) it was determined this product was not fractured and had no claim against it.A supplemental report was sent to void this mdr.The product was added to the associated product list below.Additional associated products: 178366 cps sm sht spdl w pins 600lbf lot# 567750, 178512 cps nut co-cr-mo alloy lot# 278090 178535 cps centering sleeve 13mm lot# 567750.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, h10.  visual inspection of the returned device exhibits signs of use and has fractured in centering sleeve.Sem analysis of the fractured product showed shear ductile dimples flowing in different directions (going around the fracture surface).These fracture artifacts are consistent with the torsional overload mode of fracture.Review of the device history records identified no related deviations or anomalies during manufacturing.The compression nut is compatible to be used with thre anchor plug, sleeve and spindle, however entire construct compatibility cannot be determined as part information for the entire construct was not provided.No medical records were provided.This complaint is confirmed.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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
No further event information available at the time of this report.

• 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: 16150098
• Report Number: 0001825034-2023-00075
• Device Sequence Number: 7470458
• 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,Followup,Followup
• Report Date (Section B): 04/28/2023

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: N/A
• Device Catalogue Number: 178552
• Device Lot Number: 148700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 01/19/2023; 04/27/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/15/2023; 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Male