MAUDE Adverse Event Report: ETHICON, INC. ETHICON 18 GAUGE WIRE; SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Device Problems Break (1069); Corroded (1131); Loose or Intermittent Connection (1371); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2014

Event Type  malfunction  

Event Description

The complaint received states: the patient reported that she had been diagnosed with a 3 mm displacement of the elbow in 2011.A doctor recommended physical therapy and other physicians suggested surgery for the displacement ; there was also a fracture, which the patient says could not be identified via x-ray.On (b)(6) 2012, the patient was implanted with two synthes 2.0 mm kirschner wires and one synthes 100 mm long 6.5 mm cancellous bone screw.In addition to the synthes products, one ethicon 18 gauge wire was used in the procedure.The patient reported that immediately after the surgery she began having pain and was forced to immobilize the elbow.The screw and kirschner wires were removed during a procedure in (b)(6) 2012.An attempt was made later on (b)(6) 2014 to remove the ethicon wire.During the removal the wire was found to be rusty, broken , loose and migrated.Update 7/15/14:1 x-ray received.Update 7/17/14 8 x-rays received.Two x-rays were dated (b)(6) 2012, and four noted as single plane; all x-rays of the elbow, side not designated.Update 8/11/14 verified correct date of initial implants as (b)(6) 2011.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ETHICON 18 GAUGE WIRE
• Type of Device: SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 17536728
• MDR Text Key: 321192025
• Report Number: MW5143612
• Device Sequence Number: 1
• Product Code: GAQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2014

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1