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

Model Number	1443-3301
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Rep reports that doctor performed a hammertoe procedure on (b)(6) 2019.After prepping the joint and preparing for the implant, doctor placed the crosstietm implant first into the proximal phalanx.Rep says that he did not like his placed position of the implant and decided to remove it and attempt to replace it.When removing the crosstietm, rep says that doctor admits that he put too much downward force on the implant causing it to break into 2 pieces.
Additional Manufacturer Narrative
The following internal, crossroads lot history records of the following sterile implants/instruments, and individual 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.Description part number lot number crosstietm implant kit 3.0mm x 3.0mm x 0deg with universal inserter - sterile packed 1443-3301 101932 crosstietm peek implant 3.0mm proximal od x 3.0mm distal od, 0 deg - component 100004 101891 instrument, crosstietm universal inserter, assembly - component 121220 101566.

• 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: 15501529
• Report Number: 3020584246-2022-00029
• Device Sequence Number: 18104916
• Product Code: HWC
• UDI-Device Identifier: 00815432022069
• UDI-Public: 00815432022069
• Combination Product (Y/N): N
• PMA/510(K) Number: K151270
• 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: 12/01/2021
• Device Model Number: 1443-3301
• Device Catalogue Number: 1443-3301
• Device Lot Number: 101932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2017
• 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