MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER TEAR DROP GUIDE WIRE KNEE INSTRUMENT

Model Number N/A

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). (b)(6). Reporter had indicated that product will be returned. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that foreign substances were inside of the sterile packages. No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

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.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed. The tear drop guide wire with its packaging is returned and from the returned product analysis it was determined that two small particles were found in one end of outer pouch seal area and this particulate matter is found to be acceptable per packaging criteria. Device history record was reviewed and no discrepancies were found. As package found to be within specification, no further corrective, preventive or field actions have resulted after the 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: ZIMMER TEAR DROP GUIDE WIRE
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7383821
• MDR Text Key: 104028791
• Report Number: 0001822565-2018-01911
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK101622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 47249009700
• Device Lot Number: 63880351
• Other Device ID Number: (01)00689024094789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A