MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3325-0380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
On (b)(6) 2020: a sales order was placed for an elongated g3 nail as replacement for a broken one in a patient.The patient seems to have developed a bone tumor in the proximal left femur.On 2016: an elongated gamma3 nail left was placed in the left femur back in 2016.On (b)(6) 2016: a secondary tumor was found in the left proximal femur.The patient had already prostate cancer.On (b)(6) 2016: a 3325-0380s gamma3 long nail kit r2.0, ti left, ø11x380 mm x 125° was placed in the left femur.On (b)(6) 2019: at a control the nail is still intact, but the tumor is expanding.On (b)(6) 2020: patient experienced pain in his left proximal femur.On (b)(6) 2020: patient experienced severe pain in his left proximal femur.On (b)(6) 2020: an x-ray shows that the nail is broken at the level of the lag screw.On (b)(6) 2020: a sales order was placed for an thicker elongated g3 nail as replacement for a broken one in a patient.On (b)(6) 2020: a 3525-3380s gamma3 long nail kit r1.5, ti left, ø13x380 mm x 125° was placed.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.The received device inspection revealed the following: the received nail was completely broken in the webs of proximal, at the lag screw position.The evaluation of the broken part¿s surface revealed that the breakage originated from the anterior web.A smooth surface, as well as visibility of lines of rest, confirmed the breakage to be a fatigue fracture.Starting from the anterior web with an incipient crack, the breakage progressed through the cross-section.Based on the provided medical records, the medical opinion was sought from an experienced independent medical expert which revealed the following; ¿the previous operation in 2016 was indicated well as it was a clear palliative situation.The bone was stabilized with the nail.Three years after the cancer proceeded and a fracture occurred.About that time, it was clear that sooner or later the nail would break.The new operation with a nail must be questioned.No stable situation will ever occur in a metastasis.So, after six months again nail breakage may occur.In this case-depending on the patient¿s overall health status (life expectancy, general health) a revision and restoration of the fracture with a tumor prosthesis may have been a better choice.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.Based on the investigation the root cause was attributed to a patient related issue.The failure was caused due to patients¿ condition (tumor, prostate cancer) the bone was not healed and the nail was broken in a fatigue manner.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
(b)(6) 2020 a sales order was placed for an elongated g3 nail as replacement for a broken one in a patient.The patient seems to have developed a bone tumor in the proximal left femur.2016: an elongated gamma3 nail left was placed in the left femur back in 2016.Additionally reported: (b)(6) 2016 : a secondary tumor was found in the left proximal femur.The patient had already prostate cancer.(b)(6) 2016: a 3325-0380s gamma3 long nail kit r2.0, ti left, ø11x380mm x 125° was placed in the left femur.(b)(6) 2019: at a control the nail is still intact, but the tumor is expanding.2020-01-17: patient experienced pain in his left proximal femur.(b)(6) 2020: patient experienced severe pain in his left proximal femur.(b)(6) 2020: an x-ray shows that the nail is broken at the level of the lag screw.(b)(6) 2020: a sales order was placed for an thicker elongated g3 nail as replacement for a broken one in a patient.(b)(6) 2020: a 3525-3380s gamma3 long nail kit r1.5, ti left, ø13x380mm x 125° was placed.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM 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; DE D-24232
• MDR Report Key: 9718033
• Report Number: 0009610622-2020-00055
• Device Sequence Number: 2401358
• Product Code: HSB
• UDI-Device Identifier: 07613153313533
• UDI-Public: 07613153313533
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 3325-0380S
• Device Catalogue Number: 33250380S
• Device Lot Number: K02884E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/20/2020
• 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: 74 YR