MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SAW BLADES OXFORD KNEE RESECTION PROCEDURE (3-PACK) CEMENTED FITS; BLADE, SAW

Catalog Number 506078

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is completed, a follow-up mdr will be submitted.

Event Description

It was reported that there was black color debris in the sterile package.This was discovered prior to arrival at hospital.No adverse events have been reported as a result of the malfunction.There was no patient involvement.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

No additional event information available.

• Brand Name: SAW BLADES OXFORD KNEE RESECTION PROCEDURE (3-PACK) CEMENTED FITS
• Type of Device: BLADE, SAW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8416944
• MDR Text Key: 138917166
• Report Number: 0001825034-2019-01096
• Device Sequence Number: 1
• Product Code: GFA
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 506078
• Device Lot Number: 316389
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1