MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOBAND¿ CP DYNAFORCE®; SCREWDRIVER

Model Number	DynaForce Plate Sterile Instrument Kit
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A mtp surgery was performed on (b)(6) 2020.The uni-axial screw would not seat fully.The surgeon attempted to remove with an h-10 g-source driver and pulled the screw from the hole.The surgeon placed a 3.0 non-locking screw and commented that the screw did not bit into the bone.The surgeon placed a 3.0 non-locking screw and commented that the screw did not bit into the bone.No defects were identified for the crossroad implant that was used.The device failure category is currently unknown.Potentially, the plate/screw/driver were misaligned and the surgeon placed excessive torque on the driver causing the driver to stick to the screw.Excessive force attempting to remove the driver caused the screw to be pulled out of the bone.The event included the following screws: part number 1500-3016 lot number 500212, 500394, 500471, 3.0mm x 16mm locking screw.Part number 15nl-3016, lot number 400013, 3.5mm x 16mm non-locking screw.Part number 1500-3012, lot number 500211, 3.0 x 12 locking screw.
Event or Problem Description
An mtp surgery was performed on (b)(6) 2020.The uni-axial screw would not seat fully.The surgeon attempted to remove with an h-10 g-source driver and pulled the screw from the hole.The surgeon placed a 3.0 non-locking screw and commented that the screw did not bit into the bone.

• Brand Name: MOTOBAND¿ CP DYNAFORCE®
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis, tn
• MDR Report Key: 9801771
• Report Number: 3011421599-2020-00004
• Device Sequence Number: 10957054
• Product Code: HXX
• UDI-Device Identifier: 00815432027187
• UDI-Public: 00815432027187
• Combination Product (Y/N): N
• PMA/510(K) Number: K173710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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: 08/15/2021
• Device Model Number: DynaForce Plate Sterile Instrument Kit
• Device Catalogue Number: 1500-4700
• Device Lot Number: 104184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/06/2020
• 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