MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. DART-FIRE; SCREW, FIXATION, BONE

Model Number D1N20016S

Device Problem Failure to Advance (2524)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the screw was not biting in the bone and backed out after attempting to insert in the bone.During insertion of the screw the bone cracked.

• Brand Name: DART-FIRE
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12038081
• MDR Text Key: 257391693
• Report Number: 0001043534-2021-00110
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00840420120380
• UDI-Public: 00840420120380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D1N20016S
• Device Catalogue Number: D1N20016S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 30 YR
• Patient Weight: 80