MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R, R1500 T2 FEMUR Ø9X280 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1828-0928S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	07/25/2017
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 is not available for return, device is still implanted.
Event or Problem Description
It was reported: primary t2 femoral retrograde surgery was performed on (b)(6) 2017.Approx.2 months after the surgery, the nail breakage at the proximal screw hole was found.On (b)(6) 2019, a fracture at the site of the nail breakage was suspected.A revision surgery was not planned at present.
Additional Manufacturer Narrative
The reported event was confirmed based on the x-rays provided.A device inspection was not possible since the affected device was not returned for investigation.Provided x-rays were reviewed by the medical expert and the following medical statement was provided; the fracture line is in the middle third of the femur, but more proximal.The load occurs at the proximal part of the nail, which is in this case the thinner, more vulnerable part of the nail.The fracture is a simple but oblique fracture with an orientation in the frontal plane, leading to an elevated movement in the frontal plane as well.It appears that instead of the oblong hole for dynamization surgeon used both ap-oriented proximal screw holes and the fracture gap can still be seen in the postoperative x-ray from the beginning of june.If the surgeon used only the ap-oriented holes, this can lead to massive load on the last screw hole, which is located nearest to the fracture.If that hole would have been used by the surgeon with a medial-lateral oriented screw the movement in the frontal plane would have been reduced massively.It is most likely, that the nail breakage would not have occurred.Due to insufficient information and product not returned for investigation the exact root cause could not be provided.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.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported: primary t2 femoral retrograde surgery was performed on 5/12/2017.Approx.2 months after the surgery, the nail breakage at the proximal screw hole was found.On december 2019, a fracture at the site of the nail breakage was suspected.A revision surgery was not planned at present.
Event or Problem Description
It was reported: primary t2 femoral retrograde surgery was performed on (b)(6) 2017.Approx.2 months after the surgery, the nail breakage at the proximal screw hole was found.On (b)(6) 2019, a fracture at the site of the nail breakage was suspected.A revision surgery was not planned at present.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation.And matches the alleged failure.The device inspection revealed the following: the nail broke within the fourth distal nail hole; the nail hole shows no signs of drilling or screw insertion.The breakage surface shows mainly a smooth structure with lines of rest, indicating that the main part of the nail broke in a fatigue fracture.The other surface parts are rough, indicating that these parts broke spontaneous in a forced brittle rest fracture.The extraction marks show at the end cap.Based on the provided x-rays, medical opinion was sought from experienced medical expert which is as follows: "the fracture line is in the middle third of the femur, but more proximal.The load occurs at the proximal part of the nail, which is in this case the thinner, more vulnerable part of the nail.The fracture is a simple but oblique fracture with an orientation in the frontal plane, leading to an elevated movement in the frontal plane as well.Instead he used both ap-oriented proximal screw holes and the fracture gap can still be seen in the postoperative x-ray from the beginning of (b)(6).This leads to massive load on the last screw hole, which is located nearest to the fracture.If that hole would have been used by the surgeon with a medial-lateral oriented screw the movement in the frontal plane would have been reduced massively.It is most likely, that the nail breakage would not have been occurred, then." 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 user related issue.The failure was caused due to inadequate handling during implantation i.E.(the surgeon should treat patient antegrade technique instead of retrograde technique.The fracture line is in the middle third of the femur, but more proximal.The load occurs at the proximal part of the nail, which is in this case the thinner, more vulnerable part of the nail.The surgeon uses only the ap-oriented holes.This leads to massive load on the last screw hole, which is located nearest to the fracture).If any additional information is provided, the investigation will be reassessed.

• Brand Name: FEMORAL NAIL, A/R, R1500 T2 FEMUR Ø9X280 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; DE D-24232
• MDR Report Key: 9587677
• Report Number: 0009610622-2020-00017
• Device Sequence Number: 19698286
• Product Code: HSB
• UDI-Device Identifier: 04546540200259
• UDI-Public: 04546540200259
• Combination Product (Y/N): N
• PMA/510(K) Number: K081152
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2020

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: 07/31/2018
• Device Model Number: 1828-0928S
• Device Catalogue Number: 18280928S
• Device Lot Number: K056962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 02/25/2020; 05/07/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 03/20/2020; 06/02/2020
• 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: Other; Required Intervention