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

Model Number	1442-1814
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint was received by mail through an fda medical device report (mdr) that was written by a patient.Allegedly, the patient states that they have a defective and broken clip that has caused limping, back misalignment and knee pain.The patient is convinced the clip was broken and defective at the time of implantation, according to the report (mw5086568).
Additional Manufacturer Narrative
Upon review of the patient submitted mdr to the fda, the complaint suggests that the motoclip implant was defective and broken when it was implanted.However, there is no objective evidence to confirm this complaint.The mdr says the surgery was for a 2nd tmt and 3rd tmt fusion.The patient further alleges that the clip has caused pain, limping, back misalignment, and right knee pain.The mdr states the device is available for evaluation, but no information is provided.The following lhr records were investigated and no information was found to suggest the device was not within specifications.Description: part number, lot number, motoclip super elastic fusion system 18mm x 14mm x 14mm 1442-1814 101909, motoclip super elastic fusion system 18mm x 14mm x 14mm 1442-1814 101848.

• 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: 15501680
• Report Number: 3020584246-2022-00027
• Device Sequence Number: 12116439
• Product Code: JDR
• UDI-Device Identifier: 00815432023325
• UDI-Public: 00815432023325
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K142727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 01/12/2019
• Device Model Number: 1442-1814
• Device Lot Number: 101909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2017
• 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 Sex: Unknown