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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVS 2.7MM DIA DRL; BIT, DRILL

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BIOMET ORTHOPEDICS COMP RVS 2.7MM DIA DRL; BIT, DRILL Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 09/18/2015
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.The device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, number 1 states, ¿surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.¿.
 
Event Description
It was reported that patient underwent an unknown procedure on (b)(6), 2015, subsequently, the tip of the screw drill fractured during the procedure.The fracture tip was removed from the patient and a new tip was used to complete the procedure.This event resulted in a procedural delay of thirty to sixty minutes.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
 
Manufacturer Narrative
Examination of returned device found no evidence of product non-conformance.Evaluation found the cutting edge was worn and an excessive amount of torque had been applied to the drill during use, which may have resulted in the fracture due to a torsional overload.
 
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Brand Name
COMP RVS 2.7MM DIA DRL
Type of Device
BIT, DRILL
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key5128508
MDR Text Key27504797
Report Number0001825034-2015-04160
Device Sequence Number1
Product Code HTW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Followup
Report Date 12/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date12/31/2023
Device Model NumberN/A
Device Catalogue Number405889
Device Lot Number518350
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/05/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/14/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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