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

Model Number	1806-1002
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "there were problems with insertion when the tibial nail was driven in.Impact dome and nail pick-up presumably defective.Item is 10 years old.Item has been re-processed 100 times.".
Event or Problem Description
As reported: "there were problems with insertion when the tibial nail was driven in.Impact dome and nail pick-up presumably defective.Item is 10 years old.Item has been re-processed 100 times." 10/5/2021: additional information received: nail was successful inserted, but the surgeon want to be sure, that the upcoming cases are save ( the nail adapter is correct ).That¿s why they wanted to check the nail adapter.The strike plate was damaged by them.The patient has no damage or consequences.At least the strike plate is more than 10 years old and it was for instance too much power.
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 handle and strike plate presents significant impact marks.The devices were manufactured in 2004, so it can be said that they have performed their function in the previous surgeries as intended without any reported failure.Since they have been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.The fatigue of the material under bending stresses could have induced pre-damage to the material which would have finally gave in because of torsional overload.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 instructs user that: ¿do not hit instruments unless they are specifically intended for impaction.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.The stryker "instructions for cleaning, sterilization, inspection and maintenance" help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.¿ based on investigation, the root cause was attributed to a normal wear related issue.The device was manufactured in 2004, so it can be said that it has performed its function in the previous surgeries as intended without any reported failure.Since they have been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.If any further information is provided, the complaint report will be updated.

• 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: 12446961
• Report Number: 0009610622-2021-00682
• Device Sequence Number: 4060702
• Product Code: LXH
• UDI-Device Identifier: 04546540196538
• UDI-Public: 04546540196538
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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: KHI041044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2004
• 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