MAUDE Adverse Event Report: CROSSROADS EXTREMITY SYSTEMS MINIBUNION IMPLANTS AND INSTRUMENTS; SCREWDRIVER

Catalog Number GS 86.1608

Device Problems Fracture (1260); Migration (4003)

Patient Problem No Information (3190)

Event Date 06/11/2019

Event Type  malfunction  

Event Description

During a distal bunion surgery performed using crossroads products, the doctor was performing the osteotomy portion of the procedure and the lateral cortex of the first metatarsal split leaving a small bone prominence on the captial fragment.In the same surgery during the tightening of the 3.0mm locking screw into the plate, the tip of the screwdriver broke off and was stuck in the plate.Doctor decided to leave the tip in the patient and continue completing the surgery.Doctor has no plans to revise patient.At 12 weeks follow-up the screwdriver tip migrated, and doctor says it is captured in a soft tissue envelope.

• Brand Name: MINIBUNION IMPLANTS AND INSTRUMENTS
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway ste 140; memphis TN 38119
• Manufacturer (Section G): CROSSROADS EXTREMITY SYSTEMS; 6055 primacy parkway; memphis TN 38119
• Manufacturer Contact: 6055 primacy parkway; memphis, TN 38119 ; 9012218406
• MDR Report Key: 9279450
• MDR Text Key: 177666760
• Report Number: 3011421599-2019-00014
• Device Sequence Number: 1
• Product Code: HXX
• 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: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GS 86.1608
• Device Lot Number: 5231809 OR 5231902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR