MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS LLC MOTOCLIP SUPERELASTIC FUSION SYSTEM; SINGLE/MULTIPLE COMPONENT BONE FIXATION APPLIANCE, BONE STAPLE

Catalog Number	7009-0909KT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause analysis underway to determine potential contributing factors of failure.
Event or Problem Description
Date of initial surgery is (b)(6) 2017.The doctor implanted two 9mm dynaforce implants dorsally accross the first ipj.At 4 week routine post-op visit the doctor discovered 1 fractured implant and non-union of fusion site.Doctor plans to continue to monitor patient and update us if a revision surgery is performed.

• Brand Name: MOTOCLIP SUPERELASTIC FUSION SYSTEM
• Common Device Name: SINGLE/MULTIPLE COMPONENT BONE FIXATION APPLIANCE, BONE STAPLE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS LLC; 6055 primacy parkway; suite 140; memphis TN 38119
• MDR Report Key: 8453804
• Report Number: 3011421599-2018-00002
• Device Sequence Number: 193599
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

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 Expiration Date: 09/12/2019
• Device Catalogue Number: 7009-0909KT
• Device Lot Number: 500068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR