MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND; DYNABUINION

Model Number	7100-LP18-R
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
At routine follow-up, the surgeon identified the anti-drift bolt was through the plate at 2 weeks post-op.At 6 weeks post-op, the surgeon notes that the im angle is increased.The patient is asymptomatic, and no revision is planned.
Additional Manufacturer Narrative
The lot history records of the sterile and individual component parts were reviewed in their entirety during the investigation.These records included quality inspection records, component inspection records, component print specification, component supplier certificates of conformance, supplier inspection certificates, raw material certificates of conformance, and supplier certificates of conformance.No non-conformances were found in any records that were reviewed that would have contributed to the device failure.7100-lp18-r, 501122, dynabunion plate 18mm - right - sterile, 270306, 2020001097, dynabunion plate 18mm - right, 15lp-3538 501116, dynabunion anti-drift bolt 3.5 x 38mm -sterile, 270328, 104482, dynabunion anti-drift bolt 3.5 x 38mm, 1500-4851 501226, anti-drift bolt reamer kit -sterile, 280296, 104544, 0.054"x6" coated k-wire, 280298, 104501, instrument, drill bit 2.5mm cannulated.

• Brand Name: MOTOBAND
• Common Device Name: DYNABUINION
• 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: 15501543
• Report Number: 3020584246-2022-00049
• Device Sequence Number: 7848948
• Product Code: HRS
• UDI-Device Identifier: 00815432028870
• UDI-Public: 00815432028870
• Combination Product (Y/N): N
• PMA/510(K) Number: K193452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

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 Model Number: 7100-LP18-R
• Device Catalogue Number: 7100-LP18-R
• Device Lot Number: 5001122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2020
• 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 Sex: Unknown