MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NATURAL NAIL CORTICAL SCREW; TRAUMA PROSTHESIS

Catalog Number 47248402750

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the outer packaging was not sealed upon receipt.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.Product was returned with the packaging in an opened condition; the tyvek on the outer cavity has been partially pulled open and is still attached to the thermal cavity, with evidence of proper sealing of the lid in the form of dry glue completely covering the exposed sealing edge.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined.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 NATURAL NAIL CORTICAL SCREW
• Type of Device: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6053684
• MDR Text Key: 58303379
• Report Number: 0001822565-2016-03891
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK083497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 47248402750
• Device Lot Number: 63222817
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1