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

Model Number	1442-1010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lhr was reviewed for the kit (p/n 1442-1010 lot 101500) and the pick list revealed the following lots were used for each of the parts.Implant (p/n 1402-1010 lot 101222).Inserter (p/n 100024 lot 101278).Loading block (p/n 220070 lot 101287).All of the previously mentioned lhrs were reviewed and no evidence was found to suggest that any of the parts did not meet specifications prior to distribution.Previous investigations have revealed that an inexperienced who is unfamiliar with loading the implant onto the inserter is more likely to experience this failure mode.
Event or Problem Description
While the nurse was attempting to load the implant onto the inserter she had difficulty doing so and the rep felt as if the legs of the inserter might have been bent or weakened in the process.After mentioning this to the doctor, the doctor tested the legs of the inserter while the implant was loaded and one leg of the inserter immediately broke with ease.The broken pieces were discarded and another kit was opened and successfully used.

• 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: 15501764
• Report Number: 3020584246-2022-00018
• Device Sequence Number: 15411907
• Product Code: JDR
• UDI-Device Identifier: 00850310006083
• UDI-Public: 00850310006083
• Combination Product (Y/N): N
• PMA/510(K) Number: K181410
• 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: 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: 03/24/2019
• Device Model Number: 1442-1010
• Device Lot Number: 101500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2016
• 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 Sex: Unknown