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

Catalog Number	7100-5H15
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plate listed previously was used in conjuction with the implants listed below as a total construct for bone fragment osteotomy fixation and joint arthrodesis.In addition to the non union, the nitinol implant listed below experienced mechanical failure and the 28mm screw backed out of the plate.Nitinol staple implant - dynaforce himax implant pn-7115-1515kt, lot-500167, udi-(b)(4); non-locking screws listed in next section.Plate non-locking screw - motoband cp non-locking screw 3.5mmx14mm pn-1500- 3514, lot 101314 udi-(b)(4).Plate non-locking screw - motoband cp non-locking screw 3.5mmx22mm, pn-1500- 3522, lot 102347, udi-(b)(4).Plate non-locking screw - motoband cp non-locking screw 3.5mmx28mm pn-1500- 3528, lot 500099, udi-(b)(4).
Event or Problem Description
During routine follow up visit, it was discovered that a screw had backed out of the plate, the nitinol staple implant had experience mechanical failure, and the joint was not fused.Screw was removed during office visit on (b)(6) 2018.Revision surgery will be performed to remove the plate.Revision date has not yet been scheduled.Date of original surgery is (b)(6) 2018.Patient was non-complaint regarding post-op protocol.Patient has poor bone quality and is a smoker.X-ray image included.

• Brand Name: MOTOBAND CP IMPLANT SYSTEM
• Common Device Name: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway; suite 140; memphis TN 38119
• MDR Report Key: 8444572
• Report Number: 3011421599-2018-00003
• Device Sequence Number: 277836
• Product Code: HRS
• UDI-Device Identifier: 00815432023660
• UDI-Public: 00815432023660
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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: 08/10/2018
• Device Catalogue Number: 7100-5H15
• Device Lot Number: 500051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• 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: Other
• Patient Age: 56 YR