MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISCOVERY PROV LOCK SCREW; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Degraded (1153); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 414896 disc condyle prov male/female 145780, 414877 disc 4x75mm right ulna trial 7555919, 414837 disc 5x100mm right hum trial 7555023.Foreign -(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 the elbow arthroplasty the screw could not be disengaged from the trails after trial reduction.No impact to the patient or surgery was noted.A delay of 15- 30 mins was noted.No additional information is available at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Locking screws along with the humeral and ulna trial are returned for evaluation.Functional check showed that the screw would rotate, however would not come out of the device.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information is available to report.

• Brand Name: DISCOVERY PROV LOCK SCREW
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8270188
• MDR Text Key: 133837111
• Report Number: 0001825034-2019-00046
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• 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: 414806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1