MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MOTOCLIP; STAPLE, FIXATION, BONE

Model Number	1418-1818
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lhrs were reviewed for both the motoclip kit lot (lot 101611, ref (b)(4)) and for the motoclip implant lot (lot 101269, ref (b)(4)).There was no evidence to suggest the device did not meet specification prior to distribution.A phone call was made to the rep regarding the case and the rep stated that the doctor is not displeased with the product.According to the rep, the doctor stated that the failure may likely be due to improper preparation of the joint.
Event or Problem Description
Attached image was sent over by the distributor.The 18x18x18 implant was broken at a 3-month follow up visit.Currently, the surgeon is not planning to do anything.The patient is doing well.Broken implant was left in patient.

• Brand Name: MOTOCLIP
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6423 shelby view dr.; suite 101; memphis TN 38134
• Manufacturer Contact: 6423 shelby view dr; suite 101; memphis, TN 38134 ; 9012218406
• MDR Report Key: 15501657
• Report Number: 3020584246-2022-00014
• Device Sequence Number: 14766467
• Product Code: JDR
• UDI-Device Identifier: 00815432023158
• UDI-Public: 00815432023158
• Combination Product (Y/N): N
• PMA/510(K) Number: K181410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

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: 07/27/2018
• Device Model Number: 1418-1818
• Device Lot Number: 101611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2017
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Male