MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, RIGHT T2 GTN Ø8X380 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18510838S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that patient was treated with a stryker gtn2 nail on (b)(6) 2018 after femoral fracture.After 4 months, with normal load, it has been determine that the nail has bent.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the nail significantly bent in medio-lateral direction.The original geometry in the medio-lateral direction is straight.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.As per the dhr, surgeon used an expired implant.The product was manufactured in june 2012 and product was used in surgery on (b)(6) 2018.No indications of material, manufacturing or design related problems were found during the investigation.However, the nail design, material and strength were successfully tested and specified during development; the nails are qualified for their specified application under normal conditions.Referring to the above appearances of the nail, extraordinary high forces are required to cause such a deformation/ bending of a nail.A direct trauma (e.G.Accident, fall), a sudden stumbling or extremely high postoperative loads are the most probable causes.However further information about the event and its circumstances were not provided although requested for several times.As no patient data or information about the post implant activity were available, it could not be determined if the patient had been compliant to the surgeon¿s instructions.Based on the information given above the cause of the case is attributed to the patient.With available information a deficiency of the device could not be verified.A review of the labeling did not indicate any abnormalities.Ifu clearly instructs user that: ¿in many instances, adverse results may be clinically related rather than device related.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, osteomalicia, 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.¿ improper alignment can cause a mal-union of the bone and/or bending, cracking or even breakage of the device.¿ if any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that patient was treated with a stryker gtn2 nail on (b)(6) 2018 after femoral fracture.After 4 months, with normal load, it has been determine that the nail has bent.
Additional Manufacturer Narrative
The lot code shown on the patient record label (k680335ra) indicates that the device has been repacked by the manufacturer.During this process the product was also re-sterilized.The new packaging and labeling shows the modified lot code k680335ra (instead of k680335), a different manufacturing date (b)(6) 2017) and expiry date (b)(6) 2022).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.
Event or Problem Description
It was reported that patient was treated with a stryker gtn2 nail on (b)(6) 2018 after femoral fracture.After 4 months, with normal load, it has been determine that the nail has bent.

• Brand Name: FEMORAL NAIL, RIGHT T2 GTN Ø8X380 MM
• 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: 8601225
• Report Number: 0009610622-2019-00244
• Device Sequence Number: 14001598
• Product Code: HSB
• UDI-Device Identifier: 04546540647221
• UDI-Public: 04546540647221
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 18510838S
• Device Lot Number: K680335RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 08/12/2019; 09/16/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 09/06/2019; 09/25/2019
• 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