MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MINIBUNION LOCKING SCREW

Catalog Number 3100-3016LK

Device Problem Use of Device Problem (1670)

Patient Problem Not Applicable (3189)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

The minibunion screw was also used in conjunction with the following products: minibunion plate 3.5mm offset short, part #: 3100-0030, lot #: 500737; minibunion non-locking screw 2.7mm x 14mm, part #: 3100-2714nl, lot #: 500719.

Event Description

Doctor implanted a mini bunion implant into a patient for a distal bunion correction procedure on (b)(6) 2019.The hole for a distal 3.0mm locking screw was prepared for in the bone.Doctor placed the screw into what he thought to be the hole that he prepared and locked it to the plate.However, during a follow-up visit an x-ray was taken that showed the screw completely missed the bone and was not securing the distal capital fragment.Doctor performed a revision surgery on (b)(6) 2019 to re-open the incision and remove the screw.Then, he placed the screw properly into the original hole that was drill in the first surgery.No explantation of any product was performed.

• Brand Name: MINIBUNION LOCKING SCREW
• Type of Device: SCREW
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• Manufacturer Contact: 6055 primacy parkway ate 140; memphis, TN 38119 ; 9012218406
• MDR Report Key: 9142759
• MDR Text Key: 163116375
• Report Number: 3011421599-2019-00011
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/19/2019
• Device Catalogue Number: 3100-3016LK
• Device Lot Number: 500726
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2019
• 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: 51 YR