MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TWIST OFF SCREW; SCREW, FIXATION

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the package in which the instrument was located is not sealed.This incident was detected in the warehouse of the customer.No adverse events have been reported as a result of this malfunction as there was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Report source: foreign - (b)(6).Reported event was confirmed by review of the provided picture which shows the non-conformity of the bag seal.Visual and dimensional evaluations of the returned product verified the device to be the correct size.No packaging was returned with the product.Dhr was reviewed and no discrepancies were found.The investigation concluded that the reported event was an isolated faulty error by the operator during the sealing process.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

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

• Brand Name: TWIST OFF SCREW
• Type of Device: SCREW, 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: 7018351
• MDR Text Key: 92811185
• Report Number: 0001825034-2017-09942
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K962233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P2812
• Device Lot Number: 4416F
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1