MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS LLC MOTOBAND CP IMPLANT SYSTEM; SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE

Catalog Number	7R50-0018
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A submission attempt was initially made for this mdr on 09/27/2018.At the time of the submission, the acknowledgement messages were viewed on fda webtrader and it was noted that the status was listed as delivered under the acknowledgement and sent details sections.The arrow button to download the html text was not noticed at the time and the submission error message.The error messages were for exceeding the 50 character max limit and an invalid device problem code (3110).The nitinol staple implant within the plate and staple construct exhibited mechanical failure in both legs.The information for the nitinol staple is listed below.Brand name: motoclip himax implant system.Catalog number: 17118-1818kt, lot numer: 103010, exp date: 04/05/2020, udi: (b)(4), product code: jdr.Along with the nitinol staple implant that broke in the plate and staple construct, a screw also exhibited mechanical failure.Brand name: motoband cp locking screw 3.0mm x 18mm.Catalog number: 1500-3018, lot numer: 500105, exp date: 09/01/2022, udi: (b)(4), product code: hwc.
Event or Problem Description
3 month routine post op follow up visit revealed failure of the motoband cp implant system to provide adequate fusion at the fusion site due to broken hardware.Dynaforce staple implant experienced mechanical failure in both legs.Additionally, one of the screws experienced mechanical failure as well.The doctor stated the patient was non-compliant.The joint will be revised but a revision date has not been scheduled.X-ray image will be included.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Common Device Name: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS LLC; 6055 primacy parkway; suite 140; memphis TN 38119
• MDR Report Key: 8443484
• Report Number: 3011421599-2018-00005
• Device Sequence Number: 18907902
• Product Code: HRS
• UDI-Device Identifier: 00815432025015
• UDI-Public: 00815432025015
• Combination Product (Y/N): N
• PMA/510(K) Number: K173710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/24/2018

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: Health Professional
• Device Expiration Date: 02/20/2020
• Device Catalogue Number: 7R50-0018
• Device Lot Number: 500190
• 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: 03/22/2019
• 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
• Patient Age: 62 YR