MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND CP IMPLANT SYSTEM; PLATE, FIXATION, BONE

Model Number	15LP-3536
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dynabunion system with anti-drift bolt was implanted (b)(6) 2021.Approximately 3 months later after routine follow-up, the sales representative reported that the anti-drift bolt backed out.The representative did not report that the abd was removed.The representative did not report that the patient had clinical symptoms such as pain associated with the anti-drift bolt back-out.Non-conformance was not identified based on the lots that would contribute to this failure mode.Potentially, force from weight-bearing with normal walking motion caused the screw to back-out.Screw back-out is a known failure mode of screws.The following devices were implanted with the anti-drift bolt: ref: 15nl-3018, ln: 400040, qty: 2, product name: motoband cp, non-locking screw, 3mm x 18mm.Ref: 15nl-3018, ln: 400091, qty: 1, product name: motoband cp, non-locking screw, 3mm x 18mm.Ref: 7118-1818, ln: 501371, qty: 1, product name: implant single pack, dynaforce himax, 18 x 18 x 18.Ref: 7100-lp18-r, ln: 501290, qty: 1, product name: dynabunion plate right 18mm.
Event or Problem Description
The dynabunion system with anti-drift bolt was implanted (b)(6) 2021.Approximately 3 months later after routine follow-up, the sales representative reported that the anti-drift bolt backed out.The representative did not report that the abd was removed.The representative did not report that the patient had clinical symptoms such as pain associated with the anti-drift bolt back-out.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: 6423 shelby view dr.; suite 101; memphis, TN 38134 ; 9012218406
• MDR Report Key: 15501551
• Report Number: 3020584246-2022-00055
• Device Sequence Number: 5212547
• Product Code: HRS
• UDI-Device Identifier: 00815432028825
• UDI-Public: 00815432028825
• Combination Product (Y/N): N
• PMA/510(K) Number: K193452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2022

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: Health Professional
• Device Expiration Date: 06/19/2025
• Device Model Number: 15LP-3536
• Device Catalogue Number: 501187
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Sex: Unknown