MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MINIBUNION; PLATE, FIXATION, BONE

Model Number	3100-0030
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The original bunion correction was performed on (b)(6) 2020 with no crossroads products used.The bunion correction was revised on (b)(6) 2020 using the crossroads minibunion system for fixation of the bunion correction.The surgeon reports the non-locking screw failed.X-ray evidence reveals that the non-locking screw missed the lateral cortex of the 1st metatarsal shaft and was floating in the osteotomy site intraoperatively.No non-conformances were identified in review of manufacturing records.Screw back-out may be due to inadequate fixation intra-operatively.Minibunion screws were removed in addition to the plate: ref: 3100-0030, ln: 501225, qty: 1 product name: minibunion 3.5mm offset plate short.Ref: 3100-3022lk, ln: 500729, qty: 1 product name: minibunion locking screw 3.0mm x 22mm.Ref: 3100-2720nl, ln: 501024, qty: 1 product name: minibunion non-locking screw 2.7mm x 20mm.
Event or Problem Description
A bunion correction was revised on (b)(6) 2020 using the crossroads minibunion system for fixation of the bunion correction.The surgeon reports the non-locking screw failed.X-ray evidence reveals that the non-locking screw missed the lateral cortex of the 1st metatarsal shaft and was floating in the osteotomy site intraoperatively.Bunion correction was revised on (b)(6) /2020 using the crossroads minibunion system for fixation of the bunion correction.The surgeon reports the non-locking screw failed.X-ray evidence reveals that the non-locking screw missed the lateral cortex of the 1st metatarsal shaft and was floating in the osteotomy site intraoperatively.

• Brand Name: MINIBUNION
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• MDR Report Key: 11776380
• Report Number: 3011421599-2021-00005
• Device Sequence Number: 3535711
• Product Code: HRS
• UDI-Device Identifier: 00815432027149
• UDI-Public: 00815432027149
• Combination Product (Y/N): N
• PMA/510(K) Number: K190658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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: 08/17/2022
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 501225
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR