MAUDE Adverse Event Report: OSTEOMED, LLC ACTIVATION WIRE, 82MM; EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Model Number	216-0307
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported (event date unknown) logic jr activation wire broke post-op on the right side.Based on information received the case has gone well and a good outcome has been achieved.No further information is available.
Additional Manufacturer Narrative
The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The reported device was not received for evaluation.The device history record (dhr) was reviewed for lot number reported, and no discrepancies were identified.According to the dhr, all parts were manufactured and inspected according to specification.A current inventory review of lot 1167071 took place and found three (3) items on-hand in the main warehouse.These items were inspected per their validated inspection methods against the validated drawing.All parts had passing results.A review of the complaint database revealed no other complaints for this device within a two-year period.The information received from the complainant described the breakage happening after the adjustment of the wire fifteen (15) days after the initial procedure.Although it cannot be confirmed, the user may have contributed to the failure based on the reported complaint event.However, the root cause could not be conclusively determined.
Additional Manufacturer Narrative
Additional information was received on 06 april 2023 providing patient age, date of birth, and weight, initial reporter information, and device information.Further details regarding the reported event were also provided.It was reported the initial implant procedure occurred on (b)(6) 2023, and the distraction protocol commenced.During routine follow up on (b)(6) 2023, the x-ray showed the activation wire was broken.The distraction protocol used was to adjust 2 times per day and 2 circles per adjustment.The adjustment was performed by the same person.Further information received on 12 april 2023, indicated on (b)(6) 2023, after it was determined the activation wire was broken, the physician stated the difference in distance to achieve the physician's expected result was 3mm; however, no further action was needed as distraction had been achieved and was satisfactory.On (b)(6) 2023, the logic jr distractors and activation wires were explanted/removed in a planned procedure as part of the protocol for distraction in infants (the device is intended to be removed once distraction is achieved).The investigation is still in progress and a follow up report will be submitted upon completion of the investigation.

• Brand Name: ACTIVATION WIRE, 82MM
• 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: 16560724
• Report Number: 2027754-2023-00004
• Device Sequence Number: 12152793
• Product Code: MQN
• UDI-Device Identifier: 00845694004466
• UDI-Public: (01)00845694004466(10)1167071(30)1(11)220215
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 216-0307
• Device Catalogue Number: 216-0307
• Device Lot Number: 1167071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023; 04/25/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/12/2023; 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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
• Patient Sex: Male
• Patient Weight: 5 KG
• Patient Race: Asian