MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIPASS PLASTIC NITINOL DISP X1; PUSHER, SOCKET

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 10/13/2014

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).(b)(4).Product has been received by zimmer biomet.Complaint sample was evaluated and the reported event was confirmed.The failure mode was general handling damage.The product functioned as intended and did not cause any major delay or risk to patient.The 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.The investigation results concluded that the reported event was due to customer error.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

Bipass suture punch bent during surgery.Another bipass suture punch was used to complete the procedure.This caused a delay of approximately 10 minutes.

• Brand Name: BIPASS PLASTIC NITINOL DISP X1
• Type of Device: PUSHER, SOCKET
• 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: 6901124
• MDR Text Key: 87877996
• Report Number: 0001825034-2017-07423
• Device Sequence Number: 1
• Product Code: HXO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 902093
• Device Lot Number: 135910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2014
• 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