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

Model Number	3100-0030
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon reports removal of the minibunion device approximately 2 months post-operatively.The (b)(6) female initially underwent double osteotomy and hallux valgus correction with placement of minibunion for hallux valgus and a staple at the akin osteotomy.Additionally, soft tissue anchors were placed across the dip and pop joints of the 2nd and 3rd toe.The patient presented with swelling, redness, and superficial drainage after oral antibiotics.The plate and screws (minibunion) were removed.The motoclip remains implanted.The surgeon notes that the 1st metatarsal was stable.No additional hardware was placed in the 1st metatarsal.Swelling and irritation resolved after hardware removal.No non-conformances were identified in review of manufacturing records.Minibunion screws were removed in addition to the plate: ref: 3100-0030 ln: 501230 qty: 1 product name: minibunion offset.Ref: 3100-3022lk ln: 501197 qty: 1 product name: 3.0mm x 22mm locking screw.Ref: 3100-2714nl ln: 501199 qty: 1 product name: 2.7mm x 14mm non-locking screw.
Event or Problem Description
The surgeon reports removal of the minibunion device approximately 2 months post-operatively.The (b)(6) female initially underwent double osteotomy and hallux valgus correction with placement of minibunion for hallux valgus and a staple at the akin osteotomy.Additionally, soft tissue anchors were placed across the dip and pop joints of the 2nd and 3rd toe.The patient presented with swelling, redness, and superficial drainage after oral antibiotics.The plate and screws (minibunion) were removed.The motoclip remains implanted.The surgeon notes that the 1st metatarsal was stable.No additional hardware was placed in the 1st metatarsal.

• 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: 11730323
• Report Number: 3011421599-2021-00008
• Device Sequence Number: 3832618
• 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: 04/05/2021
• 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: 04/27/2021
• 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