MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DISTAL TARGETING DEVICE FEMUR RETROGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2353-3907
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "when checking the drill passage before inserting the nail, distal targeting device could not be attached to the nail adapter.The locking lever on the targeting device did not move at all.Due to poor function, the procedure was changed to the use of a radiolucent drill and the surgery was completed.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was seized on the locking mechanism 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 document review.A review of the labeling did not indicate any abnormalities.In the case presented a patient should be treated with a t2alpha retrograde nail.When checking the drill passage before inserting the nail, the distal targeting device could not be attached to the nail adapter.Instead a radiolucent drill was used and the surgery was completed.The returned target presented with a seized locking bolt.Seizing material can be avoided by lubrication of the movable part.This process is required per cleaning instruction.Functional checks required in the labelling.Thus, the cause of the event was classified as user related.
Event or Problem Description
As reported: "when checking the drill passage before inserting the nail, distal targeting device could not be attached to the nail adapter.The locking lever on the targeting device did not move at all.Due to poor function, the procedure was changed to the use of a radiolucent drill and the surgery was completed.".

• Brand Name: DISTAL TARGETING DEVICE FEMUR RETROGRADE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16014778
• Report Number: 0009610622-2022-00597
• Device Sequence Number: 20689503
• Product Code: HSB
• UDI-Device Identifier: 07613327411843
• UDI-Public: 07613327411843
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• 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): 04/24/2023

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: 2353-3907
• Device Catalogue Number: 23533907
• Device Lot Number: KP474377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 74 KG