MAUDE Adverse Event Report: OSTEOMED, LLC LOGIC JR. DISTRACTOR, RIGHT 52MM; EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Model Number	216-1001
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing and inspection records were reviewed, and no anomalies were noted.A review of the complaint database revealed no other complaints related to this device or this issue within the review timeframe.The distractor, part-number 216-1001 was returned for evaluation.Upon inspection, it was signs of usage/wear such as scratches were noted on the surface of the returned distractor.Visual inspection was performed by quality assurance technician, who observed that the threads appeared damaged, but it was unclear what could cause the damage.Functional testing was also performed by inserting a pin gauge, into the threads; however, the gauge would not fully insert or turn inside of the distractor.The reported activation wire that was used during the reported event was not returned for evaluation.Based on the information received and the investigation performed, the root cause could not be determined.
Event or Problem Description
It was reported during a mandibular distraction surgery on the right mandible of a pediatric patient, the right distractor was secured with screws.The activation wire was inserted to adjust the distractor, but the wire would not turn.The right distractor was removed and was tested by the surgeon once removed but would not work.The same activation wire was used in the left distractor and appeared to "jam" during the second turn; however, they were able to get the activation wire to work in the left distractor to complete the left sided distraction.The reported activation wire was left in the left distractor in order to continue to complete the course of the patient's distraction protocol.Another distractor was used on the patient's right side to complete the surgery.This issue prolonged the surgery by three (3) hours.No other adverse patient consequences were reported.

• Brand Name: LOGIC JR. DISTRACTOR, RIGHT 52MM
• Common Device Name: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 19669425
• Report Number: 2027754-2024-00034
• Device Sequence Number: 6917524
• Product Code: MQN
• UDI-Device Identifier: 00845694004466
• UDI-Public: (01)00845694004466(10)1178969(30)1(11)230518
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 216-1001
• Device Catalogue Number: 216-1001
• Device Lot Number: 1178969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Race: Asian