MAUDE Adverse Event Report:; KIT, FRAME

; KIT, FRAME

Back to Search Results

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 04/07/2017

Event Type malfunction

Event Description

Tightening tool "(b)(6)" handle broke and metal tightener fell on the floor into pieces.

Event Description

Tightening tool "angie" handle broke and metal tightener fell on the floor into pieces.

Event Description

Tightening tool "angie" handle broke and metal tightener fell on the floor into pieces.

1 Device was Involved in the Event
Type of Device	KIT, FRAME
MDR Report Key	6696505
MDR Text Key	94788458
Report Number	6696505
Device Sequence Number	1
Product Code	JEY
Combination Product (y/n)	N
Reporter Country Code	US
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	User Facility
Reporter Occupation	Other
Type of Report	Initial,Followup,Followup
Report Date	06/12/2017
1 Patient was Involved in the Event
Is this a Product Problem Report?	Yes
Device Operator	Physician
Was Device Available for Evaluation?	Yes
Is the Reporter a Health Professional?	No
Was the Report Sent to FDA?	Yes
Date Report Sent to FDA	06/12/2017
Event Location	Hospital
Date Report to Manufacturer	06/12/2017
Initial Date Manufacturer Received	Not provided
Initial Date FDA Received	07/10/2017
Supplement Dates Manufacturer Received	Not provided Not provided
Supplement Dates FDA Received	08/24/2017 10/17/2017
Was Device Evaluated by Manufacturer?	Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device?	No
Type of Device Usage	N
Patient Sequence Number	1
Patient Age	43 YR