MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GUIDE WIRE GRIPPER; PASSER, WIRE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00249003200, impaction head, unknown; 00249000300, cephalomedullary targeting guide standard, unknown.Report source, foreign - the event occurred in (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 01747, 0001822565 - 2018 - 01746.

Event Description

It was reported that the items broke during an im nailing procedure.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001822565-2018-03977.

Manufacturer Narrative

Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: GUIDE WIRE GRIPPER
• Type of Device: PASSER, WIRE
• 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: 7369082
• MDR Text Key: 103420753
• Report Number: 0001822565-2018-01748
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00249001200
• Device Lot Number: 61571814
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 04/24/2018; 07/03/2018
• Supplement Dates FDA Received: 05/22/2018; 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2010
• 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