MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X400MM X 130; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3330-0400S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Date of Event	01/10/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
As reported: "[.] the patient underwent a revision surgery, on (b)(6) 2014, after a gamma nail implantation in 2013, due to a reduction of fracture of the left femur.On (b)(6) 2014, a delay in consolidation and breaking of the device was ascertained.".
Additional Manufacturer Narrative
The reported event could be confirmed with the help of report of medical-legal technical consultancy provided for investigation.The device inspection was not possible as the product was not returned 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿the following are the most frequent adverse effects involving the use of internal fracture fixation devices: delayed union or non-union of the fracture site.These devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.Conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ formal medical opinion was sought from an experienced independent medical expert as below; "this can really not be assessed with the x-rays.There is a dislocated subtrochanteric fracture described, which is typically associated with a high amount of failure.Besides the x-rays i did not find any further information on additional disease, age and bmi of the patient or on postoperative recommendations regarding weight bearing.These informations would be necessary for a sound assessment of the case." 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.However, one of the possible root causes of the nail breakage is patient related i.E.Delayed consolidation/healing.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "[.] the patient underwent a revision surgery, on (b)(6) 2014, after a gamma nail implantation in 2013, due to a reduction of fracture of the left femur.On (b)(6) 2014, a delay in consolidation and breaking of the device was ascertained.".

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X400MM X 130
• 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: 10667354
• Report Number: 0009610622-2020-00563
• Device Sequence Number: 17154817
• Product Code: HSB
• UDI-Device Identifier: 07613153313809
• UDI-Public: 07613153313809
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: 09/30/2015
• Device Model Number: 3330-0400S
• Device Catalogue Number: 33300400S
• Device Lot Number: K106589
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 01/29/2021
• 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: 52 YR