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

Model Number	1443-3311
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot history records of the sterile and individual component parts were reviewed in their entirety during the investigation.These records included quality inspection records, component inspection records, component print specification, component supplier certificates of conformance, supplier inspection certificates, raw material certificates of conformance, and supplier certificates of conformance.No non-conformances were found in any records that were reviewed that would have contributed to the device failure.1443-3311 101473 crosstietm 3.0 x 3.0 x 10o sterile.100003, 101383, crosstietm 3.0 x 3.0 x 10o.
Event or Problem Description
During surgery on (b)(6) 2020, the surgeon was implanting crosstie implant.The implant broke during implantation.The implant was removed, and another crosstie implant was utilized.The surgical delay was limited and no patient surgical complications.The implant was removed, and another crosstie implant was utilized.

• Brand Name: CROSSTIE
• 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: 15501695
• Report Number: 3020584246-2022-00047
• Device Sequence Number: 15392348
• Product Code: HWC
• UDI-Device Identifier: 00815432022076
• UDI-Public: 00815432022076
• Combination Product (Y/N): N
• PMA/510(K) Number: K151270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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: 05/01/2021
• Device Model Number: 1443-3311
• Device Catalogue Number: 1443-3311
• Device Lot Number: 101473
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2016
• 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: 24 YR
• Patient Sex: Female