MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL ULNAR BEARING ASSEMBLY TOOL; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Mechanical Problem (1384); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 instrument clamp was found loose and was not allowing the ulnar bearings to be seated fully on the ulnar component.No additional information is available at this time.

Event Description

No additional information is available to report at this time.

Manufacturer Narrative

The follow up report is being submitted to relay additional information received: complaint sample was evaluated and the reported event was not confirmed.Visual inspection of the device did not show any physical damage.Functional check was performed and the device performed as intended.The device history records were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.A definite root cause cannot be determined as returned device functioned as intended.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.

• Brand Name: NEXEL ULNAR BEARING ASSEMBLY TOOL
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7908039
• MDR Text Key: 121710279
• Report Number: 0001822565-2018-05187
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: PK123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• 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: 00840108100
• Device Lot Number: 63213944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1