MAUDE Adverse Event Report: CONMED CORPORATION / LINVATEC CORPORATION D/B/A CONMED LINVATEC C-WIRE .062" SPADE (1.57) OLIVE PIN; PIN, FIXATION, SMOOTH

Lot Number 1177841

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/27/2022

Event Type  Injury  

Event Description

Pt undergoing podiatry surgery and c-wire.062 spade (1.57mm) fracture and retained piece of 1.3cm remained in the medial cuneiform.Lot 1177841, ref (b)(4) conmed corporation.Fda safety report id #: (b)(4).

• Brand Name: C-WIRE .062" SPADE (1.57) OLIVE PIN
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): CONMED CORPORATION / LINVATEC CORPORATION D/B/A CONMED LINVATEC
• MDR Report Key: 14829685
• MDR Text Key: 294842408
• Report Number: MW5110511
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00505004400
• UDI-Public: 00505004400
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/22/2022

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 Lot Number: 1177841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 156 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White