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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.2/2.7 MM SOFT TISSUE GUIDE INSTRUMENT TRAUMA

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ZIMMER BIOMET, INC. 2.2/2.7 MM SOFT TISSUE GUIDE INSTRUMENT TRAUMA Back to Search Results
Model Number N/A
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (udi): n/a. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020-03345. Will be returned.
 
Event Description
It was reported that a 2. 7 drill bit was involved along with a 2. 0/2. 7 double drill guide. The surgeon was holding the drill guide in his hand with 2. 7 drill bit through the 2. 7 hole and attached to drill. When the drill was fired to turn the drill bit in the guide testing before use in the patient the drill bit was lodged and stuck in guide. Drill bit seized immediately and broke.
 
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Brand Name2.2/2.7 MM SOFT TISSUE GUIDE
Type of DeviceINSTRUMENT TRAUMA
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 Key10460780
MDR Text Key205913862
Report Number0001825034-2020-03220
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number233500004
Device Lot Number516349
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

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