MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3425-1380S

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

As reported: "on (b)(6) 2020, a prophylactic nailing was realized in case of imminent fracture.A nail fracture was confirmed after metal removal on (b)(6) 2020.".

Event Description

As reported: "on (b)(6) 2020, a prophylactic nailing was realized in case of imminent fracture.A nail fracture was confirmed after metal removal on (b)(6) 2020.".

Manufacturer Narrative

The reported event could be confirmed with the help of x-rays provided and matches the alleged failure mode.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: ¿contraindications - conditions presenting an increased risk of failure include: bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fixation of the devices.Other medical or surgical conditions which would preclude the potential benefit of surgery.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.¿ formal medical opinion was sought from an experienced independent medical expert as below; ¿the treatment method should have been considered against the background of the life expectancy of the patient.Maybe a joint replacement would have been an alternative.The bone cannot stabilize because it is metastatically altered.As mentioned by the hcp the breakage is indeed a typical fatigue problem if a fracture does not heal.With the metastasis the situation will keep unstable as the fracture can never heal.Therefore, the treatment has to be regarded as palliative.In the case that one uses a nail for such an indication he should be aware, that if the life expectancy is longer than six months something like that can always happen as the nail is for temporary stabilization and not foreseen to take the load for a longer period.Depending on the prognosis (expected lifetime) of the patient a joint replacement with a dual head prosthesis should be considered for the revision here-otherwise the same problem may occur in six months again.¿ based on investigation, the root cause was attributed to a user related issue.As per medical opinion ¿with the metastasis the situation will keep unstable as the fracture can never heal.Therefore, the treatment has to be regarded as palliative.In the case that one uses a nail for such an indication he should be aware, that if the life expectancy is longer than six months something like that can always happen as the nail is for temporary stabilization and not foreseen to take the load for a longer period.¿ so the nail implantation was chosen despite the contradiction (condition presenting an increased risk of failure) ¿bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation of the devices.Other medical or surgical conditions which would preclude the potential benefit of surgery.¿ depending on the prognosis (expected lifetime) of the patient a joint replacement with a dual head prosthesis should be considered for the revision here-otherwise the same problem may occur in six months again.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125
• Type of Device: 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: 10484701
• MDR Text Key: 207218550
• Report Number: 0009610622-2020-00496
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613252273844
• UDI-Public: 07613252273844
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 3425-1380S
• Device Catalogue Number: 34251380S
• Device Lot Number: K0E6E99
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 61