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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. ULNAR BEARING ASSEMBLY TOOL PROSTHESIS, ELBOW Back to Search Results
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.
 
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Brand NameULNAR BEARING ASSEMBLY TOOL
Type of DevicePROSTHESIS, 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 Key7456213
MDR Text Key106404961
Report Number0001822565-2018-02160
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
PK123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00840108100
Device Lot Number63213944
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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