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

Model Number	4020-031
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/07/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: INTERMEDULLARY FIXATION ROD
• Manufacturer (Section D): ADVANCED ORTHOPAEDIC SOLUTIONS, INC.; 3203 kashiwa street; torrance CA 90505
• MDR Report Key: 9158835
• Report Number: 2032480-2019-00013
• Device Sequence Number: 16606528
• Product Code: HSB
• UDI-Device Identifier: 00848665028850
• UDI-Public: (01)00848665028850(11)190823(10)171150(240)4020-031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4020-031
• Device Catalogue Number: 4020-031
• Device Lot Number: 171150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR