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

Model Number	1806-1002
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
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
The end user has reported: event description : it¿s a new depot for t2 tibia, only use once.The nail holding screw for tibia (ref 1806-0370) got stuck in the targeting device (ref 1806-1002) with great difficulty we were able to remove it to use the second nail holding screw and we have the same problem.And impossible to connect the nail to the target device.And impossible to use the t2 tibia nail.The surgeon had to use an implant from an other company.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail holding screws were found to be damaged and worn out around the threads whereas received nail handle had no damage/wear marks.The microscopic image of the threads of the nail handle confirms that there is no damage to the threads.The received nail holding screws could be inserted to the nail handle but with a resistance and could be removed from the nail handle but with high resistance.A sample nail holding screw was used to check whether the same issue occurs but that sample nail holding screw could be inserted and removed without difficulties which confirms that the issue of jamming is due to the received nail holding screws in this case.The od (outer diameter) of the received nail holding screws was calculated using digital micrometer and the values came out to be 8.166 mm and 8.154 mm which are in range (8.13 mm ¿ 8.18 mm) as specified in the drawing.Dimensional check on the nail handle was not performed since its function was as intended.The hardness of the received nail holding screws and nail handle was tested using a hardness tester machine and the values for the nail holding screws came out to be 46.2 and 46 hrc whereas the value for the nail handle came out to be 52.1 hrc.The hardness value of nail holding screw is well within the range (45 hrc ¿ 49 hrc) as specified in the drawing.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use states: ¿always treat the instrument carefully to avoid surface damage or alterations to the geometry.The design of the instrument must not be modified in any way.Before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.During the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused by handling failure during assembling which led to damage of nail holding screws.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The end user has reported: event description : it¿s a new depot for t2 tibia, only use once.The nail holding screw for tibia (ref 1806-0370) got stuck in the targeting device (ref 1806-1002).With great difficulty we were able to remove it to use the second nail holding screw and we have the same problem¿ and impossible to connect the nail to the target device ¿ and impossible to use the t2 tibia nail.The surgeon had to use an implant from an other company.

• 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
• MDR Report Key: 10586510
• Report Number: 0009610622-2020-00548
• Device Sequence Number: 13745132
• Product Code: LXH
• UDI-Device Identifier: 04546540196538
• UDI-Public: 04546540196538
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/04/2021

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: KHI008252-8013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1