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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED ORTHOPAEDIC SOLUTIONS, INC. AOS SMALL BONE NAILING SYSTEM INTERMEDULLARY FIXATION ROD

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ADVANCED ORTHOPAEDIC SOLUTIONS, INC. AOS SMALL BONE NAILING SYSTEM INTERMEDULLARY FIXATION ROD Back to Search Results
Model Number 4020-031
Device Problem Material Fragmentation (1261)
Patient Problem Tissue Damage (2104)
Event Date 09/07/2019
Event Type  Injury  
Event Description
On (b)(6) a surgery took place for the implant of a fibular nail p/n 1527-225. The sales representative reported that during the routine reaming of the fibula, the 3. 1 mm small bone reamer head fractured into multiple pieces (p/n 4020-031). All but one piece was able to be retrieved. The remaining piece was lodged in cortical bone, and the surgeon determined that retrieval of the remaining piece would cause more damage than good to the patient. Though the lot number was retrieved from the broken reamer, the parts were not able to be returned for evaluation. The parts were disposed of immediately after the surgery. An engineering evaluation was unable to repeat the failure as described, and an exact root cause is unknown.
 
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Brand NameAOS SMALL BONE NAILING SYSTEM
Type of DeviceINTERMEDULLARY FIXATION ROD
Manufacturer (Section D)
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
3203 kashiwa street
torrance CA 90505
Manufacturer (Section G)
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
3203 kashiwa
torrance CA 90505
Manufacturer Contact
jolie krance
3203 kashiwa street
torrance, CA 90505
3115339966
MDR Report Key9158835
MDR Text Key161720097
Report Number2032480-2019-00013
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 09/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4020-031
Device Catalogue Number4020-031
Device Lot Number171150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/04/2019 Patient Sequence Number: 1
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