MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE, HUMERUS T2 HUMERUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 18060143

Device Problem Difficult to Remove (1528)

Patient Problems Cardiac Arrest (1762); Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the nail was not connected to target device with t handle.After that, the target device (1806-0143) and holding screw(1806-0163) was locked and both device were not able to be removed.Therefore, the target device was not used and same nail was implanted and the four screws were inserted with free hand technic.When the distal screw was inserted, the blood vessel damaged at the distal part of the nail and the vascular sutured.Cardiac arrest occurred due to vascular injury, but performed cardiopulmonary resuscitation, patients resuscitated.Patient did not have residual effect.The doctor requested that cause target device and holding screw locked and trouble shooting.

Event Description

It was reported that the nail was not connected to target device with t handle.After that, the target device(1806-0143) and holding screw(1806-0163) was locked and both device were not able to be removed.Therefore, the target device was not used and same nail was implanted and the four screws were inserted with free hand technic.When the distal screw was inserted, the blood vessel damaged at the distal part of the nail and the vascular sutured.Cardic arrest occurred due to vascular injury, but performed cardiopulmonary resuscitation, patients resuscitated.Patient did not have residual effect.The doctor requested that cause target device and holding screw locked and trouble shooting.

Manufacturer Narrative

The reported event that target device, humerus t2 humerus was alleged of - assembling / disassembling of nail on adapter i.E seizing nhs could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by improper handling [user-customer-learning gap errors; lack of knowledge/skill].The device inspection revealed the following: we received a target device and a nail holding screw in assembled condition for evaluation.Both devices were received in a blocked mode.Disassembling of both devices was undertaken with a drill drift but to no avail.The target device received shows traces of use.The prongs at the nail adapter portion are damaged.Significant scratches / dents at the prongs are visible.Due to the deformed prongs at the nail adapter portion assembling of the three units (nail, nhs, target device) was not possible, since the thread of the nhs only rotated without reaching the nail thread.Most likely during this process parts of the shaft and the thread abraded by friction and fretting corrosion occurred.Appearance of damage at the thread and face side of the hexagon of the nail holding screw indicates that the head have been hit by a mallet which is considered off-label use.The deformed prongs of the target device also show signs of misuse.In case of intended use such damage would not have occurred.Malfunction is usually found during pre-op inspection which is required per ifu.Pre-supposing that fully function of the target device and nail holding screw was confirmed by a pre-operative check it can be concluded that the damage presented occurred during intra-operative procedure.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.The ifu clearly instructs: ¿do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate.

• Brand Name: TARGET DEVICE, HUMERUS T2 HUMERUS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8010616
• MDR Text Key: 125200750
• Report Number: 0009610622-2018-01363
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540196071
• UDI-Public: 04546540196071
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

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: 18060143
• Device Lot Number: KME908811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 64