MAUDE Adverse Event Report: STRYKER TRAUMA KIEL STRIKE PLATE T2 FEMUR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "during an intermedullary nail case, the strike plate was stripped out of the nail adapter completely while attempting to backslap a nail out.A second strike plate was then used in order to re-insert the nail and this strike plate also failed.Neither the nail adapter or strike plates were viable and we had to resort to using the older t2 system.This delayed the case and also ended up in wasting the first nail".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the device was returned but it is not broken.However, the threads at the connection area of the device are severely damaged, which makes it impossible for the user to use the device properly, since it cannot be screwed to the other part anymore.The returned instruments show significant traces of intense and frequent use.Hitting marks are visible at the surface of the strike plate.Based on complaint history review, some potential root causes for the damaged threads are, but are not limited to: the application of a force while the device is not properly aligned with the targeting arm.An improper engagement between the delta strike plate and the targeting arm, which could have caused the deformation of the delta strike plate at the threaded area.In former events the thread of the strike plate had been damaged by excessive load application due to incorrect engagement in the counterpart.The area of damage ¿ destroyed thread in the distal section ¿ is only possible if both instruments (strike plate and nail adapter) are not in sufficient contact with each other.Subsequently, there was no appropriate thread engagement between strike plate and nail adapter.When backslapping the nail there was no tight fit between the instruments.Thread loosening under above aspect is commonly known.A natural wear of the device.Indeed, during investigation, it has been discovered that the reported device has been manufactured in 2011, and has been used ever since.As a reminder, the cleaning and sterilization guide clearly states: ""[¿] stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.For devices that may be impacted check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.[¿]"" this case can thus be classified as user related.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 or Problem Description
As reported: "during an intermedullary nail case, the strike plate was stripped out of the nail adapter completely while attempting to backslap a nail out.A second strike plate was then used in order to re-insert the nail and this strike plate also failed.Neither the nail adapter or strike plates were viable and we had to resort to using the older t2 system.This delayed the case and also ended up in wasting the first nail".

• Brand Name: STRIKE PLATE T2 FEMUR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8958121
• Report Number: 0009610622-2019-00634
• Device Sequence Number: 16784087
• Product Code: LXH
• UDI-Device Identifier: 04546540196088
• UDI-Public: 04546540196088
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 18060150
• Device Lot Number: K618437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1