MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOCLIP 15MM SUPER ELASTIC IMPLANT KIT; STAPLE, FIXATION, BONE

Model Number	1442-1515
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/07/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
A 15mm motoclip was used to fixate an austin bunionectomy.One leg of the motoclip was allegedly cut to shorten the length of the leg.Upon insertion of the clip, supposedly the legs did not appear to line up correctly with the pre drilled holes in the bone.A mallet was used to fully insert the clip into the prepared holes.Upon removal of the inserter, it was noticed that the bone cortex was cracked dorsally.No x-rays have been provided.A k-wire(s) was used to address the cracked cortex.

• Brand Name: MOTOCLIP 15MM SUPER ELASTIC IMPLANT KIT
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway; suite 140; memphis TN 38119
• MDR Report Key: 6070286
• Report Number: 3011421599-2016-00002
• Device Sequence Number: 1897059
• Product Code: JDR
• UDI-Device Identifier: 00850310006090
• UDI-Public: 00850310006090
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2016

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: 01/01/2021
• Device Model Number: 1442-1515
• Device Catalogue Number: 1442-1515
• Device Lot Number: 101154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2016
• Initial Report FDA Received Date: 11/01/2016
• 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: 59 YR