MAUDE Adverse Event Report: ARROWHEAD DE, LLC AMDT MINI-RAIL

Model Number	M715
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Congenital Defect/Deformity (1782)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgery took place on (b)(6) 2018 at the (b)(6) hospital for (b)(6).Several weeks post-op, the surgeon commented that the device was working as expected.The device was indicated to distract the bone segments in order to accomplish distraction osteogenesis and add length to the radius.On (b)(6) 2019, dr.(b)(6) contacted the company's technical representative to report that the traveling clamp seemed to be "stalled," skipping the drive threads.The clamp was not moving with the expected force and seemed to be slipping.In phone conversation with dr.(b)(6), the representative diagnosed that the release tab on the traveling clamp was not engaged properly.The surgeon loosened the release tab and settled the clamp into the threads.The doctor reported that the clamp seemed to once again move as expected.On (b)(6) 2019 during an office visit with the patient, the doctor realized that the family was turning the wrench in the wrong direction.Instead of distracting the bone segments, the patient's family was causing the device to compress the fracture.This may have been the real reason the clamp was "skipping" - the bones ends were colliding.The surgeon corrected the error and sent the patient and family on their way.The representative contacted dr.(b)(6) on fri, (b)(6) 2019.She responded on tu, (b)(6) and reported that the device was working well and transporting as expected.The patient's osteogenesis was to 9.6mm as confirmed by the 8-week radiograph she shared.On (b)(6) 2019, the surgeon said that the patient was at 1.4cm and doing well.On (b)(6) 2019, the surgeon called to inform the representative that the clamp was no longer moving to exert a distracting force.On (b)(6) 2019, the representative and one of dr.(b)(6) associates exchanged the current rail (m715) and m702 traveling clamp with replacement components in the clinic.The extreme forces of the soft tissue prevented the device from being applied with the same correction as originally applied.The soft tissue forces on the extremity caused the correction to collapse when the initial rail was removed, falling into varus.On (b)(6) 2019, the representative attended the manipulation procedure to restore the correction while the patient was under sedation.None of the bone screws were replaced.The surgeon reports that the device is functioning as expected.On inspection of the original rail following removal, the drive threads on the rail were noticeably worn.While the rail would still provide grip to the clamp's drive screw, it can be expected that the worn threads would be susceptible to slipping at lower levels of force than a new rail.
Event or Problem Description
Clamp would not advance on the rail.

• Brand Name: AMDT MINI-RAIL
• Common Device Name: AMDT MINI-RAIL
• Manufacturer (Section D): ARROWHEAD DE, LLC; 328 poplar view lane east; suite 2; collierville TN 38017
• MDR Report Key: 8640240
• Report Number: 3008817603-2019-00001
• Device Sequence Number: 1680933
• Product Code: KTT
• UDI-Device Identifier: 00855967006370
• UDI-Public: 00855967006370
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M715
• Device Catalogue Number: M715
• Device Lot Number: 3555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2019
• 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: Required Intervention
• Patient Age: 12 YR