MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS CROSSTIE INTRAOSSEOUS FIXATION SYSTEM; SCREW, FIXATION, BONE

Model Number	1444-2500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
In this case a 2.5 mm crosstie implant was inserted into the proximal phalanx.While attempting to flip the middle phalanx onto the implant, the implant broke.The implant was successfully removed and caused a minimal delay in surgery.Also in this case, two additional implants were opened but not used because the doctor decided he wanted to use a 0 degree implant rather than a 10 degree.There was no complaint or malfunction involving the two unused 10 degree implants.Broken implant was removed and another 0 degree implant was successfully used.
Additional Manufacturer Narrative
After conversation with rep, in this case a 2.5 mm crosstie implant was inserted into the proximal phalanx.While attempting to flip the middle phalanx onto the implant, the implant broke.The implant was successfully removed and caused a minimal delay in surgery.Also in this case, two additional implants were opened but not used because the doctor decided he wanted to use a 0 degree implant rather than a 10 degree.There was no complaint or malfunction involving the two unused 10 degree implants.The following lhr's were reviewed and no evidence was found to suggest that the implant did not meet specifications prior to distribution.Lot 101051 (ref 1444-2500) packaged part number.Lot 100932 (ref 100059) implant part number.

• Brand Name: CROSSTIE INTRAOSSEOUS FIXATION SYSTEM
• Common Device Name: SCREW, 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: 15501556
• Report Number: 3020584246-2022-00021
• Device Sequence Number: 5212551
• Product Code: HWC
• UDI-Device Identifier: 00850310006540
• UDI-Public: 00850310006540
• Combination Product (Y/N): N
• PMA/510(K) Number: K151270
• 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: 12/31/2020
• Device Model Number: 1444-2500
• Device Catalogue Number: 1444-2500
• Device Lot Number: 101051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2016
• 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