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

Model Number	3100-3022LK
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
At 1-month follow-up visit, the x-ray revealed that the screw had backed-out.Revision was not completed as the patient was asymptomatic.
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.3100-0030 501029, minibunion offset plate 3.5 sterile; 280115, 104245, minibunion offset plate 3.5; 3100-3022lk, 500729, 3.0 minibunion locking screw 22mm sterile; 3100-3022lk, 103493, 3.0 minibunion locking screw 22mm; 3100-2714nl, 501022, 2.7 minibunion non-locking screw 14mm sterile; 3100-2714nl, 104453, 2.7 minibunion non-locking screw 14mm; 3100-2718nl, 500721, 2.7 minibunion non-locking screw 18mm sterile; 3100-2718nl, 102678, 2.7 minibunion non-locking screw 18mm.

• Brand Name: MINIBUNION
• 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: 15501702
• Report Number: 3020584246-2022-00046
• Device Sequence Number: 7838616
• Product Code: HWC
• UDI-Device Identifier: 00815432027125
• UDI-Public: 00815432027125
• Combination Product (Y/N): N
• PMA/510(K) Number: K181872
• 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 Model Number: 3100-3022LK
• Device Catalogue Number: 3100-3022LK
• Device Lot Number: 500729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2020
• 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: 42 YR
• Patient Sex: Female