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

Model Number	1806-1005
Medical Device Problem Codes	Failure to Align (2522); Material Deformation (2976); Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2021
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: "t2 femoral nails are used in a temporary operation on the 11th.Uses long-term hospital equipment.The screw part of the reported part was deformed and the device was not fixed firmly.Insert 3 screws proximally using a device.Confirm that one of the most recent screws deviates from the screw hole.The operation ends as it is.No witness.".
Event or Problem Description
As reported: "t2 femoral nails are used in a temporary operation on the 11th.Uses long-term hospital equipment.The screw part of the reported part was deformed and the device was not fixed firmly.Insert 3 screws proximally using a device.Confirm that one of the most recent screws deviates from the screw hole.The operation ends as it is.No witness.".
Additional Manufacturer Narrative
Correction: please refer to d9/h3, h6 results & conclusion codes.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.H3 other text : device discarded.

• Brand Name: TARGET DEVICE, FEMUR 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; GM D-24232
• MDR Report Key: 11785673
• Report Number: 0009610622-2021-00505
• Device Sequence Number: 11018121
• Product Code: LXH
• UDI-Device Identifier: 04546540196545
• UDI-Public: 04546540196545
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/11/2021

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: 1806-1005
• Device Catalogue Number: 18061005
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1