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

Model Number 3100-0030

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/13/2020

Event Type  malfunction  

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 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
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• Manufacturer Contact: 6055 primacy parkway ste 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 11776380
• MDR Text Key: 265019460
• Report Number: 3011421599-2021-00005
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00815432027149
• UDI-Public: 00815432027149
• Combination Product (y/n): N
• PMA/PMN Number: K190658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2022
• Device Model Number: 3100-0030
• Device Catalogue Number: 3100-0030
• Device Lot Number: 501225
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR