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

Catalog Number	7120-2020KT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was identified as part of complaint file remediation project.Four (4) or 5 months after the initial surgery, the patient was fused so the doctor remove activity restrictions.At 8 month post-op follow up, it was discovered the hardware had failed mechanically but the joint had remained fused.The doctor scheduled hardware but will not replace hardware as the patient has experienced proper fusion.The date of removal surgery was not provided.Based upon investigation results, no defects were identified.Additional hardware used with the component previously listed: dynaforce z alpha 18mm plate part number 7100-za18 lot number 500060.Dynaforce himax single pack implant 18x18x18mm part number 7118-1818 lot number 500138.
Event or Problem Description
Nine (9) months post-op broken clip and plate were identified.Revision surgery was scheduled for hardware removal.The doctor confirmed fusion via x-ray and will not place additional hardware after removal.

• 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: 9410446
• Report Number: 3011421599-2019-00021
• Device Sequence Number: 16720811
• Product Code: JDR
• UDI-Device Identifier: 00815432023394
• UDI-Public: 00815432023394
• Combination Product (Y/N): N
• PMA/510(K) Number: K142727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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: 7120-2020KT
• Device Lot Number: 500120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• 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