MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS ANCHOR PLUG 12MM (DRILL BIT); INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  malfunction  

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 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.

• Brand Name: COMPRESS ANCHOR PLUG 12MM (DRILL BIT)
• Type of Device: 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
• MDR Text Key: 339295908
• Report Number: 0001825034-2024-00944
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304259713
• UDI-Public: (01)00880304259713(17)330728(10)497130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Sex: Prefer Not To Disclose