MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEM, LLC MOTOBAND CP IMPLANT SYSTEM; SCREW

Model Number	Implant, 3.5mm x 38mm Anti-Drift Bolt, Fully Threaded
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter states that the anti-drift bolt was removed by the surgeon approximately 3 months after the initial procedure.No pain or symptoms were reported with the screw migration.The joint was fused.The anti-drift bolt was removed, and the patient returned to full activity.
Additional Manufacturer Narrative
The reporter states that the anti-drift bolt was removed by the surgeon approximately 3 months after the initial procedure.No pain or symptoms were reported with the screw migration.The joint was fused.The anti-drift bolt was removed, and the patient returned to full activity.Non-conformance was not identified based on the lots that would contribute to this failure mode.The root cause is unknown.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 implant were also included in the contruct.Only the anti-drfit bolt was removed.Ref: 7100-lp18-l ln: 501730 qty: 1 product name: dynabunion plate 18mm-left pack-out.Ref: 7118-1818kt-c ln: 300281 qty: 1 product name: dynaforce himaxc implant kit 18x18x18.Ref: 15pl-3516 ln: 400353 qty: 1 product name: motoband cp polyaxial locking screw 3.5mm x 16 mm sterile.Ref: 1500-3522 ln: 400151 qty: 1 product name: motoband cp non-locking screw 3.5mm x 22mm sterile.Ref: 1500-3516 ln: 400342 qty: 1 product name: motoband cp non-locking screw 3.5mm x 16mm sterile.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Common Device Name: SCREW
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEM, LLC; 6423 shelby view dr; suite 101; memphis TN 38134
• Manufacturer Contact: 6423 shelby view dr.; suite 101; memphis, TN 38134 ; 9012218406
• MDR Report Key: 15723613
• Report Number: 3020584246-2022-00060
• Device Sequence Number: 20645869
• Product Code: HWC
• UDI-Device Identifier: 00815432029587
• UDI-Public: 00815432029587
• Combination Product (Y/N): N
• PMA/510(K) Number: K193452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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: 12/03/2025
• Device Model Number: Implant, 3.5mm x 38mm Anti-Drift Bolt, Fully Threaded
• Device Catalogue Number: 15FT-3538
• Device Lot Number: 400316
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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: 18 YR
• Patient Sex: Male