MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X28MM CORTICAL SCREW STE; ROD, FIXATION

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Out-Of-Box Failure (2311); Incomplete or Missing Packaging (2312)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.The evaluation stated the goods were signed in as ok by receiver.The products left biomet control in a conforming state.We utilize standard size boxes for all our outer packaging and personnel are trained to a standard operating procedure.Upon review of internal standard where the stipulation is "product shall be packed into suitable transit packaging so that adequate protection may be afforded to the product during transit to the customer" which is always the case.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation."product shall be packed into suitable transit packaging so that adequate protection may be afforded to the product during transit to the customer." dhr 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.

Event Description

It was reported that implants were damaged upon delivery.Items inside were damaged, some of the package seals were damaged although not all the cellophane wraps were damaged.One item was completely open on cellophane and outer box wrap.Only three or four screws were not damaged.

• Brand Name: 3.5X28MM CORTICAL SCREW STE
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6910178
• MDR Text Key: 88454877
• Report Number: 0001825034-2017-07678
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 850535028
• Device Lot Number: HL3AG5
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1