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

Model Number	3100-0045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Malunion of Bone (4529)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The original bunion correction was performed on (b)(6) 2019 with the crossroads minibunion products listed above.X-ray evidence immediately post-operation shows the plate not fully seated onto the shaft of the 1st metatarsal and a gap at the osteotomy site.At a 1-year post-op follow up visit, x-ray evidence shows a non-union of the osteotomy and a broken non-locking screw.The patient is vitamin d deficient.A revision surgery was performed on (b)(6) 2020 to address the non-union and remove all hardware.None of the replacement hardware used were crossroads products.No non-conformances were identified in review of manufacturing records.Potentially, the plate and non-locking screw did not have adequate fixation intra-operatively due to the plate not being seated completely into position in the metatarsal shaft.Minibunion screws were removed in addition to the plate: ref: (b)(4), ln: 500740 qty: 1 product name: minibunion 4.5mm offset plate long.Ref: (b)(4) , ln: 500726 qty: 1 product name: minibunion locking screw 3.0mm x 16mm.Ref: (b)(4) , ln: 500723 qty: 1 product name: minibunion non-locking screw 2.7mm x 22mm.
Event or Problem Description
The original bunion correction was performed on (b)(6) 2019 with the crossroads minibunion products listed above.X-ray evidence immediately post-operation shows the plate not fully seated onto the shaft of the 1st metatarsal and a gap at the osteotomy site.At a 1-year post-op follow up visit, x-ray evidence shows a non-union of the osteotomy and a broken non-locking screw.The patient is vitamin d deficient.A revision surgery was performed on (b)(6) 2020 to address the non-union and remove all hardware.None of the replacement hardware used were crossroads products.

• 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: 11747279
• Report Number: 3011421599-2021-00006
• Device Sequence Number: 11086896
• Product Code: HRS
• UDI-Device Identifier: 00815432027170
• UDI-Public: 00815432027170
• Combination Product (Y/N): N
• PMA/510(K) Number: K190658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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: 05/09/2021
• Device Model Number: 3100-0045
• Device Catalogue Number: 3100-0045
• Device Lot Number: 500740
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 04/29/2021
• 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: 36 YR