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

Model Number	3100-0030
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon implanted a short minibunion plate on (b)(6) 2020.On (b)(6) 2020, the implant was removed due to pain.No break of the minibunion screws or plates were observed.As shown in x-ray prior to removal, the dorsal flexion angle is 43.9 degree and causing pain for the patient.Minibunion was removed and replaced with mini fragment plate and screws.Based upon the investigation results, no defects were identified for the crossroads implants that was used.The device failure category is unknown.Additional implants involved in the incident include: ref: 3100-3022lk, ln: 500729, qty: 1, product name: 3.0x22 locking screw.Ref: 3100-2714nl, ln: 500719, qty: 1, product name: 2.9x14 non-locking screw.
Event or Problem Description
The surgeon implanted a short minibunion plate on (b)(6) 2020.(b)(6) 2020, the implant was removed due to pain.As shown in x-ray prior to removal, the dorsal flexion angle is 43.9 degree and causing pain for the patient.Minibunion was removed and replaced with mini fragment plate and screws.No break of the minibunion screws or plates were observed.
Event or Problem Description
The surgeon implanted a short minibunion plate on (b)(6) 2020.On (b)(6) 2020, the implant was removed due to pain.As shown in x-ray prior to removal, the dorsal flexion angle is 43.9 degree and causing pain for the patient.Minibunion was removed and replaced with mini fragment plate and screws.No break of the minibunion screws or plates were observed.
Additional Manufacturer Narrative
The surgeon implanted a short minibunion plate on (b)(6) 2020.On (b)(6) 2020, the implant was removed due to pain.No break of the minibunion screws or plates were observed.As shown in x-ray prior to removal, the dorsal flexion angle is 43.9 degree and causing pain for the patient.Minibunion was removed and replaced with mini fragment plate and screws.The explanted devices were returned and examined.Based upon the investigation results, no defects were identified for the crossroads implants that was used.The device failure category is unknown.Additional implants involved in the incident include: ref: 3100-3022lk ln: 500729 qty: 1 product name: 3.0x22 locking screw.Ref: 3100-2714nl ln: 500719 qty: 1 product name: 2.9x14 non-locking screw.

• Brand Name: MINIBUNION SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis, tn
• MDR Report Key: 10017943
• Report Number: 3011421599-2020-00009
• Device Sequence Number: 14078982
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: 12/24/2021
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 500967
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 05/18/2020
• 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: 71 YR