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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE PRECISION FLX RMR 4.5MM DISP REAMER

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BIOMET SPORTS MEDICINE PRECISION FLX RMR 4.5MM DISP REAMER Back to Search Results
Model Number N/A
Device Problems Guidewire; Fracture; Material Deformation
Event Date 08/27/2015
Event Type  Malfunction  
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 complaint related anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: under precautions; ¿intraoperative fracture or breaking of instruments has been reported¿ and "instruments that have experienced extensive use or excessive force are susceptible to fracture. " evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda. This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-03972 / 03973).

 
Event Description

It was reported patient underwent an acl procedure on (b)(6) 2015. During the procedure, a 4. 5mm precision reamer drill bit fractured when drilling the femoral tunnel. The drill bit was replaced with another 4. 5mm reamer which fractured as well. Both drill bits were removed by adjusting the chuck above the fracture and reaming out. It was noticed that the guide wire was bowed. Guide wire was straightened and a third 4. 5mm precision reamer was used to complete the procedure.

 
Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance. Evaluation of returned device found both precision flexible reamers have fractured as stated in the complaint. Both reamers fractured at the proximal end of the instrument at the beginning of the laser cur flexible slots. Reamers likely failed due to misuse; by product being put through torsional/bending overload causing flex drill to fast-fracture.

 
Event Description

It was reported patient underwent an acl procedure on (b)(6) 2015. During the procedure, a 4. 5 mm precision reamer drill bit fractured when drilling the femoral tunnel. The drill bit was replaced with another 4. 5 mm reamer which fractured as well. The fracture site was high enough that the surgeon was able to adjust the chuck of the drill and ream out. It was noticed that the guide wire was bowed. The guide wire was straightened and a third 4. 5 mm precision reamer was used to successfully complete the procedure.

 
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Brand NamePRECISION FLX RMR 4.5MM DISP
Type of DeviceREAMER
Manufacturer (Section D)
BIOMET SPORTS MEDICINE
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET SPORTS MEDICINE
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw , IN 46582
5743726700
MDR Report Key5074043
Report Number0001825034-2015-03972
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date09/30/2015
Device MODEL NumberN/A
Device Catalogue Number110004180
Device LOT Number652910
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/09/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/13/2014
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 TREATMENT DATA
Date Received: 09/14/2015 Patient Sequence Number: 1
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