MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS ANCHOR PLUG 12MM (DRILL BIT); INSTRUMENT, 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	03/12/2024
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.32-481003 compress drill guide small lot# 792700.
Event or Problem Description
It was reported the compress instrument malfunctioned, resulted in delay of approximately 30 minutes.The drill bit got stuck in the targeter and seized.A second attempt was made using a smaller targeter and the same issue happened a second time but the hcp stopped and readjusted the device and then had to freehand the transverse pin placement.The surgical technique was followed.The drill bits did fracture but all pieces were recovered prior to proceeding with the procedure.The procedure was completed satisfactorily.There was no patient harm, just the 30 min delay.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h11 the anchor plug was not returned.Visual and dimensional evaluations could not be performed.Review of the device history records identified no related deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The complaint is not confirmed.A definitive 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.

• Brand Name: COMPRESS ANCHOR PLUG 12MM (DRILL BIT)
• 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: 19036882
• Report Number: 0001825034-2024-00944
• Device Sequence Number: 8187564
• Product Code: JDI
• UDI-Device Identifier: 00880304259713
• UDI-Public: (01)00880304259713(17)330728(10)497130
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K031804
• 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): 09/27/2024

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 Model Number: N/A
• Device Catalogue Number: 178402
• Device Lot Number: 497130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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: Prefer Not To Disclose