MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW FEMUR RETROGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2353-3904
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the threads of the nail holding screw was damaged when attached to the nail.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned but as per communication the product was confirmed with no damage and found to be functional.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design-related problems were unable to be identified as the lot number was not communicated.Based on the available information and communication, the root cause is user-related as the device was found to be functional and had no damage.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: NAIL HOLDING SCREW 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: 16684648
• Report Number: 0009610622-2023-00100
• Device Sequence Number: 17965203
• Product Code: HSB
• UDI-Device Identifier: 07613327381825
• UDI-Public: 07613327381825
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 04/05/2023

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: 2353-3904
• Device Catalogue Number: 23533904
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Male