MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMER BLADE WITH PILOT HOLE; INSTRUMENTATION, KNEE

Catalog Number 00597909529

Device Problem Difficult to Insert (1316)

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

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The complaint device has not been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.Discarded.

Event Description

It was reported during a knee procedure, the patella reaming blade would not assemble with the reamer blade.Ultimately, a new blade was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not be determined with the information provided.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 Description

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

• Brand Name: PATELLA REAMER BLADE WITH PILOT HOLE
• Type of Device: INSTRUMENTATION, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8500542
• MDR Text Key: 141494622
• Report Number: 0001822565-2019-01358
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00597909529
• Device Lot Number: 64264664
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1