MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS CROSSROADS SCREW SYSTEM; Screw, fixation, bone

Model Number	1456-4040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Rep reports that during a lapidus procedure doctor used 3 screws and a staple to perform the surgery.After he placed one of the 4.0mm screws the 1.1mm k-wire instrument broke as he tried to remove it from the screw.It had to be left in the patient since it could not be retrieved.Rep reports that doctor does not have any plans to revise this patient going forward.
Additional Manufacturer Narrative
The lot history records of the following sterile implants and individual component parts were reviewed in their entirety during the investigation.These records include quality inspection procedures, component inspection records, component print specifications, component supplier certificates of conformance, supplier inspection certificates, raw material certificates of conformance, and supplier certificates of compliance.No non-conformances were found in any of these records that were reviewed.Description, part number, lot number, 4.0 headed implant prep kit including reamer - sterile, 1456-4040 103145, headed bone screw 4.0mm x 26mm - sterile, 1406-4026 102217, headed bone screw 4.0mm x 30mm - sterile, 1406-4030 102219, headed bone screw 4.0mm x 40mm - sterile, 1406-4040 102224.

• Brand Name: CROSSROADS SCREW 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: 15501539
• Report Number: 3020584246-2022-00028
• Device Sequence Number: 7848946
• Product Code: HWC
• UDI-Device Identifier: 00850310006861
• UDI-Public: 00850310006861
• Combination Product (Y/N): N
• PMA/510(K) Number: K143039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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: 09/11/2020
• Device Model Number: 1456-4040
• Device Catalogue Number: 1456-4040
• Device Lot Number: 103145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• 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 Age: 48 YR
• Patient Sex: Female