MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS DYNAFORCE HIMAX; STAPLE

Catalog Number	7118-1414KT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was identified as part of complaint file remediation project.Non-union was identified 2 months post-op.The fusion site did not properly fuse/heal.None of the implanted hardware mechanically failed.The hardware was removed during a revision surgery and no additional hardware was implanted.Patient was non-compliant with post-op protocol.The patient is also diabetic and neuropathic.The hardware was implanted on (b)(6) 2018 and removed on (b)(6) 2018.Based on the investigation results, no defects were found with the crossroads implants that were used.The device failure category is currently unknown.It is unknown if the patient followed post-operative instructions including the importance of immobilization of the treatment site using routine methods be maintained until bone healing has occurred.Additional hardware used with the component previously listed: dynaforce mpj plate 5degree valgus, 0degree dorsiflexion, 18mm, sterile packaged part number 7r50-0018 lot number 500190.
Event or Problem Description
Two (2) months post-op, a non-union was identified.A revision surgery was performed to remove the hardware.No additional hardware was replaced.Original hardware was not broken.

• Brand Name: DYNAFORCE HIMAX
• Common Device Name: STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• MDR Report Key: 9410358
• Report Number: 3011421599-2019-00020
• Device Sequence Number: 14194679
• Product Code: JDR
• UDI-Device Identifier: 00815432023356
• UDI-Public: 00815432023356
• Combination Product (Y/N): N
• PMA/510(K) Number: K142727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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: No Information
• Device Catalogue Number: 7118-1414KT
• Device Lot Number: 500162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention