MAUDE Adverse Event Report: STRYKER GMBH KIRSCHNER WIRE Ø2.0X285MM; PIN, FIXATION, SMOOTH

Catalog Number 390191

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

At 10:45 in (b)(6) 2018, the patient was treated with closed reduction and kirschner wire internal fixation for the fracture of the distal right femur due to the fracture of the external end of the right femur.When the doctor gave the patient the third kirschner wire, the kirschner wire broke and half of the kirschner wire broke in the bone.At 11:30, the doctor cut the patient's skin and part of the cartilage at the needle point, searched for the kirschner wire broken in the bone, and took it out and sutured the skin.The operative time was 12:32.The operation was originally a closed reduction operation.Because the kirschner wire was broken in the patient's bone, the operation method had to be changed to open reduction.

Manufacturer Narrative

The reported event that kirschner wire ø2.0x285mm was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by not releasing the metal button at the top of the insertion handle of the k-wire sleeve.The device inspection confirms that the k-wire is broken in two parts.A microscope inspection of the first part of the wire shows a surface specific to a ductile fracture, meaning that an extensive plastic deformation of the material can be noticed.A rough surface of the material is also very clear.This all proves that the material ruptured, and pulled appart at once, probably following the exertion of a sudden important force.The sign of a clear "cut" on the device is also very clear.This was most probably caused by not releasing the metal button of the insertion handle of the k-wire sleeve properly, which could have caused the weakening and later on the rupture of the device.As a reminder, it is clearly mentioned in the operative technique: " [.] precise alignment of the k-wire can be achieved by using a k-wire sleeve (ref 703531) through the cannulation of the plate adaptor.For increased provisional plate fixation, it is also recommended to insert a k-wire in one of the distal plate k-wire holes.This, in addition to other independently placed k-wires can help to support articular surface fragments.Remove the handle for insertion by pressing the metal button at the top of the handle.[.] ".And the ifu clearly reminds that: "[.] ¿ always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.[.] " a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

At 10:45 in (b)(6) 2018, , the patient was treated with closed reduction and kirschner wire internal fixation for the fracture of the distal right femur due to the fracture of the external end of the right femur.When the doctor gave the patient the third kirschner wire, the kirschner wire broke and half of the kirschner wire broke in the bone.At 11:30, the doctor cut the patient's skin and part of the cartilage at the needle point, searched for the kirschner wire broken in the bone, and took it out and sutured the skin.The operative time was 12:32.The operation was originally a closed reduction operation.Because the kirschner wire was broken in the patient's bone, the operation method had to be changed to open reduction.

Manufacturer Narrative

The reported event that kirschner wire ø2.0x285mm was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by the application of an important torsional bending of the material.The device inspection confirms that indeed the k-wire is broken in two parts.The surface analysis of the breakage shows that the device broke due to an important torsional bending of the material.The ductile fracture was due to the application of a great amount of force by the healthcare professional, which ripped the two surfaces apart, leaving a ¿necking¿ clearly visible on the two sides of the device.This is also logical with the steps that the healthcare professional went through according to the x-ray provided.Indeed, the k-wires were used as implants to hold the pieces of the bone in place.The tip was introduced in the bones and the shaft of the wire was bent (that is where the breakage occurred) and then cut at the surface of the skin.As a reminder the ifu clearly states that: "[.] ¿ always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.[.]" in order to avoid a similar event from happening in the future, it could be recommended that the user uses a k-wire bender (for example the stryker k-wire pliers of reference (b)(4)).This could allow the health care professional to control the amount and repartition of force that is applied on the device, and thus limit the chances of a device breakage.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

At 10:45 on (b)(6) 2018 , the patient was treated with closed reduction and kirschner wire internal fixation for the fracture of the distal right femur due to the fracture of the external end of the right femur.When the doctor gave the patient the third kirschner wire, the kirschner wire broke and half of the kirschner wire broke in the bone.At 11:30, the doctor cut the patient's skin and part of the cartilage at the needle point, searched for the kirschner wire broken in the bone, and took it out and sutured the skin.The operative time was 12:32.The operation was originally a closed reduction operation.Because the kirschner wire was broken in the patient's bone, the operation method had to be changed to open reduction.

• Brand Name: KIRSCHNER WIRE Ø2.0X285MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8228632
• MDR Text Key: 132482594
• Report Number: 0008031020-2019-00012
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 37613327072625
• UDI-Public: 37613327072625
• Combination Product (y/n): N
• PMA/PMN Number: K971962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 390191
• Device Lot Number: 05118J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 02/04/2019; 04/11/2019
• Supplement Dates FDA Received: 03/04/2019; 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other