MAUDE Adverse Event Report: OSTEOMED LOGIC, ACTIVATION WIRE, 62MM; ACTIVATION WIRE FROM THE PRODUCT LINE: LOGIC DISTRACTOR

Model Number	216-0302
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/15/2019 oateomed was notified of an incident that occur with our logic, activation wire, 62mm (part number 216-03020).It was being used as half of a bi-lateral mandible distraction surgery.Per the distributor, the plate was implanted on (b)(6) 2019 and 3 days post operation the patient was discharged home in an attempt to distract mandible 20+mm.Five (5) days post operation the patient's mom initiated distraction with supplied tool.Twelve (12) days post-operation the mother presented to dr.(b)(6) with broken left sided distractor with 5-10mm still protruding from the moving plate.Did not snap off at the joint.
Additional Manufacturer Narrative
The 62mm activation wire, p/n 216-0302, was broken twelve days post-op.The break occurred when patients' mother was attempting to remove the tool from the activation wire.The root cause for the breakage was unintended use error.There was no lot number provided; therefore, no review of the dhr was possible.A two-year review did not identify any capas or ncrs related to this instrument family, p/ns 216-030x.This is the only complaint for this issue, "activation wire broken post-op", discovered in a two-year review of the complaint database.This activation wire is a part of the logic mandibular distraction system.The logic risk document (fmea) covered an activation wire breaking post-operatively.The severity rating is a 3.Per the design risk management procedure, a rating of 3 indicates a "serious" severity level (results in injury or impairment requiring professional medical intervention).The final predicted risk level ranges from low to high depending on the potential cause.The logic instructions for use (ifu) have several warnings that are pertinent.The ifu warns against bending of the system, excessive torque on the activation wire, and excessive activity or trauma.The ifu also warns that the "patient/guardian is to be made aware of the surgical risks and possible adverse effects prior to surgery, and warned that failure to follow postoperative care instructions can cause failure of the implant and the treatment." finally, it states that during distraction, "the activation wire should be kept coaxial (aligned) with the distractor body." the logic surgical technique guide (stg), has all of the same warning and precautions as have just been quoted above from the logic ifu.This issue will be monitored through routine trending.

• Brand Name: LOGIC, ACTIVATION WIRE, 62MM
• Common Device Name: ACTIVATION WIRE FROM THE PRODUCT LINE: LOGIC DISTRACTOR
• Manufacturer (Section D): OSTEOMED; 3885 arapaho rd; addison TX 75001
• MDR Report Key: 9507758
• Report Number: 2027754-2019-00015
• Device Sequence Number: 3474680
• Product Code: MQN
• UDI-Device Identifier: 00845694004428
• UDI-Public: 00845694004428
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K062851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 216-0302
• Device Catalogue Number: 216-0302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/03/2020
• 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: Required Intervention
• Patient Age: 16 YR
• Patient Weight: 70