MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN 11X380MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1826-1138S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported: "doctor sent an x-ray showing that the t2 scn end cap was out of the nail and in the patient's joint.The reporter is unaware if a revision is scheduled to happen".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned and no other evidence was provided for evaluation.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.More information as well as the device must be available in order to determine the exact root cause.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported: "doctor sent an x-ray showing that the t2 scn end cap was out of the nail and in the patient's joint.The reporter is unaware if a revision is scheduled to happen".

• Brand Name: SUPRACONDYLAR NAIL T2 SCN 11X380MM
• 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
• MDR Report Key: 11949825
• Report Number: 0009610622-2021-00539
• Device Sequence Number: 4229672
• Product Code: HSB
• UDI-Device Identifier: 04546540379009
• UDI-Public: 04546540379009
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K023267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: 1826-1138S
• Device Catalogue Number: 18261138S
• Device Lot Number: K042EAF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR