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

Model Number	3100-0030
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Swelling/ Edema (4577)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The original bunion correction was performed on (b)(6) 2020 with the crossroads minibunion products.X-ray evidence at 2-weeks post-operation shows the plate not fully seated onto the shaft of the 1st metatarsal and minimal purchase of the non-locking screw into the lateral cortex of the shaft of the 1st metatarsal with the screw head slightly backed out from the plate.According to the surgeon, the patient had severe post-operative swelling, evidence of wound breakdown with infection, and a non-locking screw that backed-out potentially from restless leg syndrome.Non-conformance was not identified based on the lots that would contribute to these events.Screw back-out may have been due to inadequate fixation intra-operatively or due to the restless leg syndrome of the patient.The following screws were removed with the plate: ref: 3100-3024lk ln: 501198 qty: 1 product name: minibunion locking screw 3.0mm x 24mm.Ref: 3100-2722nl 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) 2020 with the crossroads minibunion products.X-ray evidence at 2-weeks post-operation shows the plate not fully seated onto the shaft of the 1st metatarsal and minimal purchase of the non-locking screw into the lateral cortex of the shaft of the 1st metatarsal with the screw head slightly backed out from the plate.According to the surgeon, the patient had severe post-operative swelling, evidence of wound breakdown with infection, and a non-locking screw that backed-out potentially from restless leg syndrome.

• 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: 11747271
• Report Number: 3011421599-2021-00007
• Device Sequence Number: 11086895
• 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: 2021
• 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): 04/27/2021

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: 08/24/2022
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 501230
• 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: 66 YR