MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR CROSSLOCK 1.7 MM SQUARE DRIVER; DRIVER, PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign ¿ events occurred in (b)(6).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.

Event Description

It was reported that during a distal volar radius plating procedure, the tip of the driver fractured off inside of a screw head.The fractured portion of the driver was unable to be retrieved from the screw head and remains in the patient.No additional patient consequences have been reported.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Concomitant medical products: 131821051, dvr lock narrow l st, 237820; 131827114, lock screw sq 2.7mm 14mm ste, 510580; 131827116, lock screw sq 2.7mm 16mm ste, 815500; 131827118, lock screw sq 2.7mm 18mm ste, 822700; 131827118, lock screw sq 2.7mm 18mm ste, 872100; 131827120, lock screw sq 2.7mm 20mm ste, 870510.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.When subjected to scanning electron microscopy (sem analysis), the driver showed indications of overload of fracture by exhibiting ductile dimples.The orientation changes of the ductile dimples on the fracture surface suggested a torsion overload.When subjected to energy-dispersive x-ray spectroscopy (eds analysis)the device's material composition was found to be consistent with product specifications.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.

• Brand Name: DVR CROSSLOCK 1.7 MM SQUARE DRIVER
• Type of Device: DRIVER, PROSTHESIS
• 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: 7111994
• MDR Text Key: 94631610
• Report Number: 0001825034-2017-10907
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 231200101
• Device Lot Number: CA5D708
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 12/06/2017; 05/10/2018
• Supplement Dates FDA Received: 01/02/2018; 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2016
• 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
• Patient Outcome(s): Disability