MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL NAIL TEAR DROP GUIDE WIRE ROD, FIXATION

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Concomitant medical products: catalog #: 47249009700, natural nail tear drop guide wire, lot # 63983829. (b)(6). 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03314.

Event Description

It was reported that there was a crease in the sealing area of the package.

Event Description

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

Manufacturer Narrative

(b)(4). Reported event was considered to be confirmed as visual evaluation of the four returned products confirmed the presence of crease and/or fold in the seal of the pouches. Device history record was reviewed and no discrepancies were found. Root cause was determined to be a manufacturing issue as the likely condition of the parts when they left zimmer biomet control is considered non-conforming based on the evaluation of the returned product. 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: NATURAL NAIL TEAR DROP GUIDE WIRE
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7611767
• MDR Text Key: 111441066
• Report Number: 0001822565-2018-03316
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 02/06/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 47249009700
• Device Lot Number: 63983832
• Other Device ID Number: (01) 00889024094789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A