MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 1.6MM KIRSCHNER WIRE; PIN, FIXATION, SMOOTH

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/05/2022

Event Type  malfunction  

Event Description

Adult female presented with a preoperative diagnosis of painful medial column, as well as painful range of motion of the patient's first metatarsophalangeal joint on the right foot.The procedure performed was a right foot tarsometatarsal fusion of the right foot with corrective osteotomy and post procedure splint application.During the procedure, the tip of the olive wire broke off in the patient's cuneiform and did not under fluoroscopy appear to be in the patient's joint.The op report reflects that following adequate osteotomy performed at the base of the first metatarsal as well as the distal aspect of the middle cuneiform, the joint was fenestrated with a drill bit, followed by placement of a bone graft on the foot, the joint was reduced.Then an olive wire was placed across the joint to maintain reduction.X-rays were taken.A dorsal plate followed by a medial plate was placed in the right foot.The k-wire was removed, and it was noted the distal tip of the olive wire did break off and remained in the medial cuneiform bone.With examination, it was determined that the k-wire did not appear to be in the patient's joint and in the center of the cuneiform bone.It was determined to leave the broken fragment in the patient's foot as it would cause more damage to the hardware, which did not appear to be affecting any additional surrounding structures.

• Brand Name: 1.6MM KIRSCHNER WIRE
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade rd,; ste 150; ponte vedra FL 32081
• MDR Report Key: 15209138
• MDR Text Key: 297692205
• Report Number: 15209138
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8395 DA
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: White