MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	33250360S
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Not reported if available.
Event or Problem Description
In (b)(6) 2018, an osteosynthesis of a subtrochanteric femur fracture using a long nail was performed in domo.On (b)(6) 2018 the patient presented with increasing pain in the left hip, without a trauma had preceded.
Event or Problem Description
In (b)(6) 2018, an osteosynthesis of a subtrochanteric femur fracture using a long nail was performed in domo.On (b)(6) 2018 the patient presented with increasing pain in the left hip, without a trauma had preceded.
Additional Manufacturer Narrative
The reported event that long nail kit r2.0, ti, left gamma3® ø11x360mm x 125° was alleged of issue k-556 (revision) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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 for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.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.As per the complaint history and risk file, pain is mostly caused by the kind of fracture, patient's general condition (osteoporosis), and primarily the respective surgical technique.The instruction for use informs the surgeon to be familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X360MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8242305
• Report Number: 0009610622-2019-00033
• Device Sequence Number: 11406841
• Product Code: HSB
• UDI-Device Identifier: 07613153313519
• UDI-Public: 07613153313519
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• 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): 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33250360S
• Device Lot Number: K068589
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR