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

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.

• Brand Name: AOS SMALL BONE NAILING SYSTEM
• Type of Device: INTERMEDULLARY 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 Key: 9158835
• MDR Text Key: 161720097
• Report Number: 2032480-2019-00013
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163014
• Number of Events Reported: 1
• 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 Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4020-031
• Device Catalogue Number: 4020-031
• Device Lot Number: 171150
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• 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