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

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - the event 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 ulnar bearing assembly tool jammed during surgery.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The instrument was returned for evaluation.Functional was performed using sample implants.The instrument was able to assemble the bearing as intended however while pressing the handles some resistance was observed.Some nicks are observed in the guiding slot causing the resistance.After application of lubricant to the instrument functioned smoothly however noticed some grinding.Device history record (dhr)was reviewed and no discrepancies were found.Investigation results concluded that operational context caused or contributed to reported event.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: ULNAR BEARING ASSEMBLY TOOL
• Type of Device: PROSTHESIS, ELBOW
• 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: 7456213
• MDR Text Key: 106404961
• Report Number: 0001822565-2018-02160
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PK123862
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• 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: 00840108100
• Device Lot Number: 63213944
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• 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