MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE; MOTOCLIP

Model Number	7009-0909KT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
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.Description: motoclip max 9mm x 9mm x 9mm - sterile, part number: 7009-0909kt, lot number: 300172.Description: motoclip max 9mm x 9mm x 9mm - component, part number: 240000-ep, lot number: 10394.
Event or Problem Description
Doctor performed routine follow-up x-ray post-operatively after akin procedure.Doctor identified that the 9mm x 9mm x 9mm clip was broken.Refer to post-operative x-ray for clip broken across the bridge.He does not plan a revision as the patient is asymptomatic.Conservative care will continue until fusion occurs.

• Brand Name: DYNAFORCE
• Common Device Name: MOTOCLIP
• 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: 15501600
• Report Number: 3020584246-2022-00039
• Device Sequence Number: 20193441
• Product Code: JDR
• UDI-Device Identifier: 00815432023288
• UDI-Public: 00815432023288
• Combination Product (Y/N): N
• PMA/510(K) Number: K142727
• 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 Expiration Date: 09/11/2021
• Device Model Number: 7009-0909KT
• Device Lot Number: 300172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2019
• 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: 60 YR
• Patient Sex: Male