MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLO-FEMORAL JOINT (PFJ) MILLING BURR STANDARD; PROSTHESIS, KNEE

Model Number N/A

Device Problems Difficult or Delayed Positioning (1157); Fracture (1260); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Udi: (b)(4).Medical products: patello-femoral joint (pfj) milling burr standard; p/n: 00592705000, l/n: 64497161; qty: 2, milling handpiece; p/n: 00592704000, l/n: 13010572, milling handpiece; p/n: 00592704000, l/n: 08010227.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00855, 0001822565-2020-00858.

Event Description

It was reported during surgery the first milling guide became loose and the surgeon was force to break it to release the handle.Subsequently, the second milling guide was used and would not seat properly.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.H3: customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted. .

Event Description

No further event information available at the time of this report.

• Brand Name: PATELLO-FEMORAL JOINT (PFJ) MILLING BURR STANDARD
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9803839
• MDR Text Key: 182616330
• Report Number: 0001822565-2020-00855
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2020
• 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: 00592705000
• Device Lot Number: 64497161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1