MAUDE Adverse Event Report: SYNTHES (USA) 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM; TEMPLATE

Catalog Number 292.20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

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, another manufacturer¿s 18 gauge wire was also 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 other manufacturer¿s wire.During the removal, the wire was found to be rusty, broken, loose, and migrated.The patient stated that the other manufacturers wire is not supposed to be intermingled with non-like alloys and has requested the material composition of the synthes product implanted in 2012; an engineer has been contacted to provide the information to the patient.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Explanted on an unknown date in (b)(6) 2012.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient was also implanted on (b)(6) 2011 with an unknown titanium rod which she reports has contributed to her injuries.The patient reports that she has lost the use of her left arm and has extensive permanent damage to her left arm bones, elbow joint and tendons.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3933845
• MDR Text Key: 4578490
• Report Number: 2520274-2014-12568
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 292.20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention