MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND DYNAFORCE DYNABUNION; PLATE, FIXATION, BONE

Model Number 15LP-3534

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

The reporter observed the anti-drift bolt (adb) backed-out at routine follow-up approximately 7 months post-op.Dynabunion as originally implanted (b)(6) 2020.Revision surgery was performed on (b)(6) 2021 replacing the adb with a crossroads 4.0mm x 34 mm headed cannulated screw and himax plus staple.The patient is recovering in a cam boot taking vitamin d and using a bone stimulator to aid with fusion.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 or the screw had limited cortical bone purchase when placed.Screw back-out is a known failure mode of screws.The following devices were also implemented with the anti-drift bolt: ref: 7100-lp18-l, ln: 501121, qty: 1, product name: dynabunion plate left 18mm.Ref: 7118-1818kt, ln: 300196, qty: 1, product name: implant kit, dynaforce himax 18 x 18 x 18.Ref: 1500-3516, ln: 400418, qty: 1, product name: motoband cp - non-locking screws 3.5mm x 16mm.Ref: 15nl-3014, ln: 400017, qty: 1, product name: motoband cp, 3mm x 14mm.

Event Description

The reporter observed the anti-drift bolt (adb) backed-out at routine follow-up approximately 7 months post-op.Dynabunion as originally implanted (b)(6) 2020.Revision surgery was performed on (b)(6) 2021 replacing the adb with a crossroads 4.0mm x 34 mm headed cannulated screw and himax plus staple.The patient is recovering in a cam boot taking vitamin d and using a bone stimulator to aid with fusion.

• Brand Name: MOTOBAND DYNAFORCE DYNABUNION
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• Manufacturer Contact: 6055 primacy parkway ste 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 12128937
• MDR Text Key: 260302217
• Report Number: 3011421599-2021-00011
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00815432028818
• UDI-Public: 00815432028818
• Combination Product (y/n): N
• PMA/PMN Number: K193452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2022
• Device Model Number: 15LP-3534
• Device Catalogue Number: 15LP-3534
• Device Lot Number: 501113
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention