MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR LOCK NARROW R ST; APPLIANCE, FIXATION

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products - ni, unknown k-wire, ni.131812051, dvr lock standard r st, unknown.131827112, lock screw sq 2.7mm 12mm ste, unknown.131827112, lock screw sq 2.7mm 12mm ste, unknown.131827112, lock screw sq 2.7mm 12mm ste, unknown.131827116, lock screw sq 2.7mm 16mm ste, unknown.131827116, lock screw sq 2.7mm 16mm ste, unknown.131827118, lock screw sq 2.7mm 18mm ste, unknown.131827114, lock screw sq 2.7mm 14mm ste, unknown.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 the k-wire was stuck and fractured in the hole of the plate which made the plate unusable.The plate was removed from the patient.The surgeon used another plate to complete the procedure.No issues from the patient were reported.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.K wire was not returned; however, a portion of the k wire was found embedded in the returned plate's corresponding hole.Therefore, the complaint is confirmed for a fractured k wire.The plate shows minor cosmetic damage, likely from the attempt to implant it.Dhr was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required.Implant compatability could not be assessed without product id of the k-wire.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 LOCK NARROW R ST
• Type of Device: APPLIANCE, 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: 7040864
• MDR Text Key: 92316486
• Report Number: 0001825034-2017-10389
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• 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: 131811051
• Device Lot Number: 146260
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention