MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZNN ANTEGRADE FEMORAL TARGETING GUIDE SYSTEM TARGETING GUIDE HANDLE SMALL; ROD, FIXATION

Model Number N/A

Device Problem Difficult to Remove (1528)

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

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Concomitant medical products: impaction head, cat#: 00249003200, lot#: 62321059.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that while impacting the impaction head instrument in order to insert a femoral nail, the impaction head instrument threads fractured off into the guide.No patient consequences occurred as a result of the malfunction, as the nail was successfully implanted.No further information has been made available.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that this device was not involved in the event.The initial report was submitted in error and should be voided.

• Brand Name: ZNN ANTEGRADE FEMORAL TARGETING GUIDE SYSTEM TARGETING GUIDE HANDLE SMALL
• 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: 7549553
• MDR Text Key: 109413371
• Report Number: 0001822565-2018-02909
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK083497
• 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
• Report Date: 06/28/2018

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: 00249009810
• Device Lot Number: 11000436
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2010
• 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