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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product - tear drop guide wire 3.0 mm diameter 100 cm length, cat#: 47249009700 lot#: 63836284; tear drop guide wire 3.0 mm diameter 100 cm length, cat#: 47249009700 lot#: 63855457.(b)(6).Product has been 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 all associated reports: 0001822565-2018-03636, 0001822565-2018-03226.

Event Description

It was reported that during a femoral nailing procedure, the guide wire gripper would no longer grip the guide wire.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed impaction marks present on the product.The 3.0 mm hole exhibits wear indicative of use.The etching of the product is faded.The wear on the holes leads to insufficient gripping of guide wires.The part was measured within specifications.The functional check revealed that the gripper fails to grip the guide wire.Device history record was reviewed and no discrepancies relevant to the reported event were found.The gripper was used in-vivo in the field for approximately (b)(4) years.The root cause of the reported event is attributed to wear and tear due to normal use.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: 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: 7804616
• MDR Text Key: 117851998
• Report Number: 0001822565-2018-03636
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

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 Model Number: N/A
• Device Catalogue Number: 00249001200
• Device Lot Number: 62597689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1