MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HANDLE T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-1002
Medical Device Problem Codes	Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that the nail holding screw (1806-0370) would not pass through the targeter attachment (1806-1002).The surgeon had to switch nail systems as the case could not be completed without these instruments.The surgeon tried the first screw and it didn¿t pass through.The surgeon tried the second with the same out come.The screws lost some of the threads while attempting to pass them through.
Event or Problem Description
It was reported that the nail holding screw (1806-0370) would not pass through the targeter attachment (1806-1002).The surgeon had to switch nail systems as the case could not be completed without these instruments.The surgeon tried the first screw and it didn¿t pass through.The surgeon tried the second with the same out come.The screws lost some of the threads while attempting to pass them through.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.We received both nail holding screws and the nail handle in disassembled condition for evaluation.Fretting marks running over the whole circumference were visible on the outer surface of the shaft of the above nail holding screw [nhs] close to the beginning of the thread.Corresponding fretting marks running over the whole circumference are also visible inside the tube of the nail handle.Further damage was not found.Fretting marks are a rare but known reaction if these materials come in contact which each other.During screwing into the nail it is possible that the nhs gets in contact with the inner surface of the tube of the nail handle and friction occurs due to a suboptimal [slight oblique] axial insertion.In combination with small tolerances it is possible that cold welding occurs.Appearance of damage indicates that the devices got jammed by ¿cold welding¿ due to friction corrosion being caused by high surface pressure.Most likely high surface pressure generated by high load applied to the nail holding screw had led to the damage found.Local surface pressure may arise when the items are assembled under misalignment.The ifu and instructions for cleaning, sterilization, inspection and maintenance include that every instrument must be cleaned, sterilized and checked successfully prior to every surgery.Furthermore, the user shall be trained and familiar with the system and operative techniques.Referring to the very long period since manufacturing [manufactured in 2013] the device has reached the end of its useful service-life and had fulfilled its tasks in former surgeries as intended, until the reported event, without problems reported.It could not be excluded that the device was pre-damaged after such a long time.A process change was already performed in 2004 to prevent fretting regarding the nail holding screw [surface coating was removed].No further actions were initiated.The returned nail holding screw was manufactured post to the change.The change does not prevent a user error due to oblique insertion.Based on the above and as nothing was reported during pre-operative check performed, which is required per ifu, the root cause of the reported event was not device related but was rather linked to an inadequate handling by the user.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.In case substantive information will become available in future the file will be reviewed and reopened.In case substantive information will become available in future the file will be reviewed and reopened.

• Brand Name: NAIL HANDLE T2 TIBIA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12304123
• Report Number: 0009610622-2021-00632
• Device Sequence Number: 19826194
• Product Code: LXH
• UDI-Device Identifier: 04546540196538
• UDI-Public: 04546540196538
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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 Model Number: 1806-1002
• Device Catalogue Number: 18061002
• Device Lot Number: KHI125882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown